Adjustable clamp systems and methods

ABSTRACT

Tissue treatment systems include an actuator handle assembly coupled with a clamp assembly having a first jaw mechanism and a second jaw mechanism. A first jaw mechanism includes a first flexible boot, a first flexible ablation member coupled with the first flexible boot, and a first rotatable jawbone disposed within the first flexible boot. A second jaw mechanism comprises a second flexible boot, a second flexible ablation member coupled with the second flexible boot, and a second rotatable jawbone disposed within the second flexible boot.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. Nonprovisional PatentApplication No. 12/971,774, filed Dec. 17, 2010, now U.S. Pat. No.9,072,522, which is a nonprovisional of, and claims the benefit of thefiling date of U.S. Provisional Patent Application No. 61/288,031 filedDec. 18, 2009. This application is also related to U.S. PatentApplication Nos. 60/337,070 filed Dec. 4, 2001; Ser. No. 10/080,374filed Feb. 19, 2002, now U.S. Pat, No. 7,753,908; Ser. No. 10/255,025filed Sep. 24, 2002, now U.S. Pat. No. 7,674,258; Ser. No. 10/272,446filed Oct. 15, 2002, now U.S. Pat. No. 6,849,075; Ser. No. 10/410,618filed Apr. 8, 2003, now U.S. Pat. No. 7,226,448; Ser. No. 11/067,535filed Feb. 25, 2005, now U.S. Pat. No. 7,785,324; Ser. No. 11/148,611filed Jun. 8, 2005, now U.S. Pat. No. 7,819,867; 61/051,975, filed May9, 2008; Ser. No. 12/255,076 filed Oct. 21, 2008, now U.S. Pat. No.8,535,307; and Ser. No. 12/463,760 filed May 11, 2009. The entirecontent of each of these filings is incorporated herein by reference forall purposes.

BACKGROUND OF THE INVENTION

Embodiments of the present invention relate generally to therapeuticsystems and methods, and more particularly, to techniques that are wellsuited for the formation of lesions in body tissue.

There are many instances where it is beneficial to perform a therapeuticintervention in a patient, using a system that is inserted within thepatient's body. One exemplary therapeutic intervention involves theformation of therapeutic lesions in the patient's heart tissue to treatcardiac conditions such as atrial fibrillation, atrial flutter, andarrhythmia. Therapeutic lesions may also be used to treat conditions inother regions of the body including, but not limited to, the prostate,liver, brain, gall bladder, uterus, and other solid organs. Typically,the lesions are formed by ablating tissue with one or more electrodes.Electromagnetic radio frequency (“RF”) energy applied by the electrodeheats and eventually kills or ablates the tissue to form a lesion.During the ablation of soft tissue (e.g. tissue other than blood, boneand connective tissue), tissue coagulation occurs, which leads to tissuedeath. Thus, references to the ablation of soft tissue are typicallyreferences to soft tissue coagulation. “Tissue coagulation” can refer tothe process of cross-linking proteins in tissue to cause the tissue tojell. In soft tissue, it is the fluid within the tissue cell membranesthat jells to kill the cells, thereby killing the tissue. Depending onthe procedure, a variety of different electrophysiology devices may beused to position one or more electrodes at the target location.Electrodes can be connected to power supply lines and, in someinstances, the power to the electrodes can be controlled on anelectrode-by-electrode basis. Examples of electrophysiology devicesinclude catheters, surgical probes, and clamps.

Currently known surgical probes which can be used to create lesionsoften include a handle, a relatively short shaft that is from 4 inchesto 18 inches in length and either rigid or relatively stiff, and adistal section that is from 1 inch to 10 inches in length and eithermalleable or somewhat flexible. One or more electrodes are carried bythe distal section. Surgical probes are used in epicardial andendocardial procedures, including open heart procedures and minimallyinvasive procedures where access to the heart is obtained via athoracotomy, thoracostomy or median sternotomy. Exemplary surgicalprobes are disclosed in U.S. Pat. No. 6,142,994, the content of which isincorporated herein by reference.

Clamps, which have a pair of opposable clamp members that may be used tohold a bodily structure or a portion thereof, are used in many types ofsurgical procedures. Lesion-creating electrodes have also been securedto certain types of clamps. Examples of clamps which carry lesioncreating electrodes are discussed in U.S. Pat. No. 6,142,994, and U.S.Patent Publication Nos. 2003/0158549, 2004/0059325, and 2004/024175, thecontents of which are incorporated herein by reference. Such clamps canbe useful when the physician intends to position electrodes on oppositesides of a body structure in a bipolar arrangement.

Although these and other proposed treatment devices and methods mayprovide real benefits to patients in need thereof, still furtheradvances would be desirable. For example, there continues to be a needfor improved ablation systems and methods that can be used by surgeonsto treat patient tissue or anatomical features having various sizes,shapes, densities, and the like. Embodiments of the present inventionprovide solutions that address the problems which may be associated withknown techniques, and hence provide answers to at least some of theseoutstanding needs.

BRIEF SUMMARY OF THE INVENTION

An electrode assembly in accordance with embodiments of the presentinvention includes an electrode that is connected to at least two powersupply lines. An electrode assembly (or a plurality of electrodeassemblies) may be used in electrophysiology devices including, but notlimited to, catheters, surgical probes and clamps. In one exemplarybipolar clamp implementation, an electrode assembly is provided on oneclamp member and a similar electrode assembly (e.g. with an electrodeand a pair of power return lines) is provided on the other clamp member.In some cases, an electrode assembly may include a single power returnline. Such a clamp may be used to form long, continuous lesions withoutthe gaps that may sometimes occur when a plurality of spaced powertransmitting electrodes are positioned opposite a plurality of spacedreturn electrodes. The individual clamp members may include rotatablejawbone members that can be adjusted to be set or fixed at desiredangular degrees about their longitudinal axis, thereby enabling asurgeon to create lesion lines in any of a variety of three dimensionalconfigurations.

Exemplary systems and methods are well suited for treating patientsexhibiting atrial fibrillation, for example by performing tissueablations and creating lesions at or near the pulmonary veins, ascardiac tissue near the base of the pulmonary veins may harbor sourcesof aberrant electrical signals that cause the left atrium to contractirregularly. By creating scar or burn tissue around these sources, whichmay be located at the base of the pulmonary veins, it is possible torestore the left atrium to sinus rhythm, so that the left atriumproperly receives signals from the SA or AV node. For example,treatments may involve forming a box lesion on cardiac tissue, so as toremove, diminish, or block off unwanted eddy currents and signals.

In some instances, jaw clamps are used to squeeze or “bite” into aportion of the left atrium, and to deliver a burning ablation to thetissue. The clamps can then be removed, leaving a circular or roundedscar. Ablation clamps can be used during a sternotomy or open chestprocedure, for example which may involve a valve repair procedure. Insome cases, ablation clamps can be used to deliver ablation during abypass surgery. Hence, embodiments of the present invention encompasstechniques for treating atrial fibrillation as part of a concomitantprocedure.

Often, the jaw clamps will squeeze together two layers of tissue. Whenthe tissue layers are pressed sufficiently tightly against one another,there may be no blood between the layers. One jaw clamp can include anactive (−) electrode, and the opposing jaw clamp can include aground/return (+) electrode. Application of energy through theelectrodes operates to heat the tissue, thereby forming a lesion.Embodiments of the present invention provide convenient and efficientmechanisms to change the orientation of the jaw clamps throughoutvarious degrees or rotation. This flexibility allows the surgeon to usea single clamp design to easily access or approach the patient anatomyfrom different directions. For example, the surgeon may choose to treatcardiac tissue using an inferior approach or using a superior approach.In some cases, the path through which the device is maneuvered maydepend on the size of the patient. For example, a physician may elect asuperior approach with a larger patient. In some cases, the path throughwhich the device is maneuvered may depend on the patient's anatomy. Forexample, when approaching the heart, the physician may wish to pursue aninferior approach due to the location of branching great vessels and theconical shape of the rib cage. In some cases, the path through which thedevice is maneuvered may depend on the location of an access port orincision. For example, if an incision is made slightly high relative tothe heart, the physician may chose a superior approach.

The clamp jaws can be oriented so that they form an ablation curve thatintersects the curve of the atrium. This intersection allows the jaws tobite into the atrium and make an encircling lesion about the base of thepulmonary veins. When holding the device handle, with the distal jawends extending away from the user, if the jaws bend to the right theycan be considered to be in a “right curve” orientation. Similarly, whenholding the device handle, with the distal jaw ends extending away fromthe user, if the jaws bend to the left they can be considered to be in a“left curve” orientation. Embodiments of the present invention encompassreversible jaw clamps, that can be switched between right curve and leftcurve orientations. Hence, embodiments provide single devices that canbe used for inferior approaches as well as for superior approaches.Similarly, embodiments provide single devices that can be used todeliver energy at or near the left pulmonary veins, as well as at ornear the right pulmonary veins. Toward this end, embodiments provideclick-jaw embodiments whereby the operator may rotate the orientation ofa curved jaw clamp by engaging an actuation mechanism or button of thedevice. Such rotation or actuation can be performed using two fingers,such as the thumb and forefinger. In some cases, the physician mayperform a squeeze-and-release motion to rotate a jaw clamp, for exampleby ninety degrees. For example, an instroke can rotate the jaw by fortyfive degrees, and an outstroke can rotate the jaw by another forty fivedegrees. During actuation, an internal jawbone may rotate within andrelative to an external flexible boot to which an electrode is attached.During jawbone rotation, opposing electrodes of a clamp device mayremain facing one another. Two squeeze-and-release motions may result ina one hundred and eighty degree rotation of the jaw clamp. Theseactuation motions can be performed without touching or engaging the jawelectrode itself. In some cases, the physician may rotate the jaw withone hand, while holding the device handle with the other hand.

In addition to the left curve and right curve orientations discussedabove, surgeons may wish to use treatment devices of the presentinvention where the jaw clamps are disposed in an “up curve”orientation, which may be useful for performing a scooping motion whennavigating down and underneath the patient's vessels. Such techniquesmay be useful where procedures benefit from special device positioning,or where procedures are performed in a smaller patient. Optionally,surgeons may wish to use treatment devices of the present inventionwhere the jaw clamps are disposed in an “down curve” orientation, whichmay be useful for performing a dome procedure. For example, thephysician may form a small cut in the atrial wall, slide one jaw insideof the atrium, and perform a superior dome lesion between the pulmonaryvein pairs while one jaw clamp is inside the atrium, and one jaw clampis on the outside.

Embodiments of the present invention may include temperature controlfeatures. For example, the amount of power delivered through one or moreelectrodes can be controlled based on the temperature of the tissue oran indicator of tissue temperature.

In one aspect, embodiments of the present invention encompass systemsand methods for forming a lesion on a tissue of a patient. An exemplarysystem may include an actuator handle assembly, and a clamp assemblycoupled with the actuator handle assembly. The clamp assembly mayinclude a first jaw mechanism and a second jaw mechanism. The first jawmechanism can have a first flexible boot, a first flexible ablationmember coupled with the first flexible boot, and a first rotatablejawbone disposed within the first flexible boot. The second jawmechanism can have a second flexible boot, a second flexible ablationmember coupled with the second flexible boot, and a second rotatablejawbone disposed within the second flexible boot. In some cases, thefirst flexible ablation member includes a serpentine electrode. In somecases, the second flexible ablation member includes a serpentineelectrode. Optionally, the first flexible ablation member can have afishbone electrode. Similarly, the second flexible ablation member canhave a fishbone electrode. The first and second flexible boots can beconfigured such that the first and second ablation members face towardeach other upon rotation of the first jawbone, the second jawbone, orboth. A treatment system may also include a cooling system having afluid return lumen, and a fluid delivery lumen disposed within the fluidreturn lumen. In some cases, a treatment system includes a pull androtate rotational assembly. In some cases, a treatment system includes aball and detent rotational assembly. In some cases, a treatment systemincludes a side ratchet rotational assembly. In some cases, a treatmentsystem includes a tuning fork rotational assembly. Optionally, atreatment system can include a radiofrequency generator capable ofdelivering a radiofrequency power signal to the clamp assembly. Thefirst ablation element can include a member selected from the groupconsisting of a radiofrequency ablation element, an infrared laserablation element, a high intensity focused ultrasound ablation element,a microwave ablation element, a cryoablation ablation element, achemical agent ablation element, a biological agent ablation element,and a radiation ablation element. In some embodiments, the first andsecond jaw mechanisms are configured to provide an ablation zone shapethat rotates as a result of rotation of the first and second jawbones.

In another aspect, embodiments of the present invention encompasstreatment systems for forming a lesion on a tissue of a patient.Exemplary treatment systems may include an actuator handle assembly, anda clamp assembly coupled with the actuator handle assembly. The clampassembly may include a first jaw mechanism and a second jaw mechanism.The first jaw mechanism may include a first flexible boot, a firstflexible ablation member coupled with the first flexible boot, and afirst rotatable jawbone disposed within the first flexible boot. Thesecond jaw mechanism may include a second flexible boot, a secondflexible ablation member coupled with the second flexible boot, and asecond rotatable jawbone disposed within the second flexible boot. Insome instances, the first flexible ablation member includes a serpentineelectrode. In some instances, the second flexible ablation memberincludes a serpentine electrode. In some instances, the first flexibleablation member includes a fishbone electrode. In some instances, thesecond flexible ablation member includes a fishbone electrode.Optionally, the first and second flexible boots can be configured suchthat the first and second ablation members face toward each other uponrotation of the first jawbone, the second jawbone, or both. In someinstances, a treatment system may include a cooling system having afluid return lumen, and a fluid delivery lumen disposed within the fluidreturn lumen. In some instances, a treatment system may include a pulland rotate rotational assembly. In some instances, a treatment systemmay include a ball and detent rotational assembly. In some instances, atreatment system may include a side ratchet rotational assembly. In someinstances, a treatment system may include a tuning fork rotationalassembly. Optionally, a treatment system may include a radiofrequencygenerator capable of delivering a radiofrequency power signal to theclamp assembly.

According to some embodiments, an ablation element can include aradiofrequency ablation element, an infrared laser ablation element, ahigh intensity focused ultrasound ablation element, a microwave ablationelement, a cryoablation ablation element, a chemical agent ablationelement, a biological agent ablation element, a radiation ablationelement, or the like. In some embodiments, the first and second jawmechanisms can be configured to provide an ablation zone shape thatrotates as a result of rotation of the first and second jawbones. Insome instances, a treatment system may include a push and releaserotational assembly.

In another aspect, embodiments of the present invention encompassmethods of delivering an ablation to a tissue of a patient. An exemplarymethod may include engaging a patient with a treatment system having anactuator handle coupled with a clamp assembly, where the clamp assemblyincludes a first jaw mechanism and a second jaw mechanism, the first jawmechanism includes a first flexible boot, a first flexible ablationmember coupled with the first flexible boot, and a first rotatablejawbone disposed within the first flexible boot, and the second jawmechanism includes a second flexible boot, a second flexible ablationmember coupled with the second flexible boot, and a second rotatablejawbone disposed within the second flexible boot. Methods may alsoinclude delivering an ablation energy through the first flexibleablation member to the tissue of the patient. In some cases, the firstflexible ablation member includes a serpentine electrode. In some cases,the second flexible ablation member includes a serpentine electrode.Optionally, the first flexible ablation member can have a fishboneelectrode. Similarly, the second flexible ablation member can have afishbone electrode. Optionally, the first and second flexible boots canbe configured such that the first and second ablation members facetoward each other throughout rotation of the first jawbone, the secondjawbone, or both. Some methods may include cooling the treatment systemwith a cooling system. Some methods may include rotating the firstrotatable jawbone with a pull and rotate rotational assembly. Somemethods may include rotating the first rotatable jawbone with a ball anddetent rotational assembly. Some methods may include rotating the firstrotatable jawbone with a side ratchet rotational assembly. Some methodsmay include rotating the first rotatable jawbone with a tuning forkrotational assembly. Some methods may include rotating the firstrotatable jawbone with a push and release rotational assembly.

In yet another aspect, embodiments of the present invention encompasstreatment systems for forming a lesion on a tissue of a patient whichmay include, for example, an actuator handle assembly, a clamp assemblyhaving a first jaw mechanism and a second jaw mechanism, a first pushand release rotational assembly coupling the actuator handle with thefirst jaw mechanism, and a second push and release rotational assemblycoupling the actuator handle assembly with the second jaw mechanism. Thefirst jaw mechanism can include a first flexible boot, a first flexibleablation member coupled with the first flexible boot, and a firstrotatable jawbone disposed within the first flexible boot. The secondjaw mechanism can include a second flexible boot, a second flexibleablation member coupled with the second flexible boot, and a secondrotatable jawbone disposed within the second flexible boot. In someinstances, the first push and release rotational assembly comprises afirst frame button and a first leaf spring. In some instances, the firstframe button includes an engagement button, an upper horizontal armhaving an upper tooth, a lower horizontal arm having a lower tooth, anda vertical arm having a vertical tooth. Optionally, the leaf spring caninclude an engagement tab, and the first push and release rotationalassembly can include a jawbone base having an engagement aperture thatreceives the engagement tab. In some instances, the first push andrelease rotational assembly includes a jawbone base having a jawbonebase tooth that can engage an upper tooth, a lower tooth, or a verticaltooth of the first frame button.

The above described and many other features and attendant advantages ofembodiments of the present invention will become apparent and furtherunderstood by reference to the following detailed description whenconsidered in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B illustrate aspects of treatment systems and methodsaccording to embodiments of the present invention.

FIG. 2 illustrates aspects of treatment systems and methods according toembodiments of the present invention.

FIG. 3 illustrates aspects of treatment systems and methods according toembodiments of the present invention.

FIGS. 4 and 4A illustrate aspects of treatment systems and methodsaccording to embodiments of the present invention.

FIG. 5 illustrates aspects of treatment systems and methods according toembodiments of the present invention.

FIGS. 6A and 6B illustrate aspects of treatment systems and methodsaccording to embodiments of the present invention.

FIG. 7 illustrates aspects of treatment systems and methods according toembodiments of the present invention.

FIGS. 8A to 8O illustrate aspects of treatment systems and methodsaccording to embodiments of the present invention.

FIGS. 9A to 9C illustrate aspects of treatment systems and methodsaccording to embodiments of the present invention.

FIGS. 10A to 10C illustrate aspects of treatment systems and methodsaccording to embodiments of the present invention.

FIG. 11A illustrates aspects of treatment systems and methods accordingto embodiments of the present invention.

FIGS. 12A and 12B illustrate aspects of treatment systems and methodsaccording to embodiments of the present invention.

FIG. 13 illustrates aspects of treatment systems and methods accordingto embodiments of the present invention.

FIGS. 14A to 14D illustrate aspects of treatment systems and methodsaccording to embodiments of the present invention.

FIG. 15 illustrates aspects of treatment systems and methods accordingto embodiments of the present invention.

FIGS. 16A to 16S illustrate aspects of treatment systems and methodsaccording to embodiments of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Embodiments of the present invention encompass systems and methods thatinvolve a treatment system having a disposable dedicated bipolar clamp.In some cases, a bipolar clamp device may include cooled RF technology.Optionally, treatment devices may include a flexible serpentine plateelectrode. Treatment devices may be adjustable for ease of use by thesurgeon in any of a variety of configurations, including a right handconfiguration, a left hand configuration, a jaws up configuration, and ajaws down configuration. The treatment device can adopt suchconfigurations as the surgeon adjustably flips or rotates the jawsthrough various degrees of angular rotation. In some cases, a treatmentdevice includes a symmetric, unified release trigger.

Turning now to the drawings, FIG. 1A illustrates aspects of a treatmentsystem 100 a according to embodiments of the present invention.Treatment system 100 a includes a clamp assembly 110 a, an actuatorassembly 120 a, and a coupling assembly 130 a in operative associationwith both the clamp assembly and the actuator assembly. Clamp assembly110 a includes a first jaw mechanism 112 a and a second jaw mechanism114 a. Coupling assembly 130 a may include a shaft or other elongatemember that allows the physician or operator to access or reach asurgical site with the clamp assembly, when the physician is holdingactuator assembly 120 a. Coupling assembly 130 a includes a proximal end132 a and a distal end 134 a. As shown here, clamp assembly 110 a iscoupled with distal end 134 a of coupling assembly 130 a, and actuatorassembly 120 a is coupled with proximal end 132 a of coupling assembly130 a. Clamp assembly 110 a is depicted in a generally closedconfiguration, such that first jaw mechanism 112 a contacts or issituated near second jaw mechanism 114 a. In some cases, a treatmentsystem may present a disposable dedicated bipolar clamp havingsingle-position jaws and a symmetric jaw-release on a plunger stylebody.

FIG. 1B illustrates aspects of a treatment system 100 b according toembodiments of the present invention. Treatment system 100 b includes aclamp assembly 110 b, an actuator assembly 120 b, and a couplingassembly 130 b in operative association with both the clamp assembly andthe actuator assembly. Clamp assembly 110 b includes a first jawmechanism 112 b and a second jaw mechanism 114 b. Coupling assembly 130b may include a shaft or other elongate member that allows the physicianor operator to access or reach a surgical site with the clamp assembly,when the physician is holding actuator assembly 120 b. Coupling assembly130 b includes a proximal end 132 b and a distal end 134 b. As shownhere, clamp assembly 110 b is coupled with distal end 134 b of couplingassembly 130 b, and actuator assembly 120 b is coupled with proximal end132 b of coupling assembly 130 b. Clamp assembly 110 b is depicted in agenerally open configuration, such that first jaw mechanism 112 b doesnot contact or is situated at a distance from second jaw mechanism 114b. The treatment system includes a serpentine electrode or ablationmember 115 b disposed on second jaw mechanism 114 b. The first jawmechanism 112 b includes a corresponding electrode or ablation member(not shown) that faces toward ablation member 115 b. In some cases, atreatment system may present a disposable dedicated bipolar clamp havingflip jaws and a symmetric jaw-release on a plunger style body.

FIG. 2 shows aspects of a treatment system 200 according to embodimentsof the present invention. Treatment system 200 includes a clamp assembly210, an actuator assembly 220, and a coupling assembly 230 in operativeassociation with both the clamp assembly and the actuator assembly.Clamp assembly 210 includes a first jaw mechanism 212 and a second jawmechanism 214. First jaw mechanism 212 is disposed proximal to secondjaw mechanism 214. The jaw mechanisms may include ablation assemblies,as well as support assemblies for holding the ablation assemblies. Forexample, as shown in FIG. 2, second jaw mechanism 214 includes anablation assembly 216 having a proximal electrode 216 a and a distalelectrode 216 b. The proximal and distal electrodes are coupled with asupport assembly 215. First jaw mechanism 212 provides a similarconfiguration, and has one or more electrodes (not shown) that facetoward electrodes 216 a, 216 b of distal jaw mechanism 214. In use, thesurgeon or operator can use the handle or actuator assembly 220 formanipulating the treatment system, opening and closing the jawmechanisms, activating ablation members such as electrodes 216 a, 216 b,and the like. Treatment system 200 can be generally configured to beintroduced through a minimally invasive sheath, trocar, or incision. Insome cases, treatment system 200 can be used in open surgicalprocedures. Coupling assembly 230 may include a shaft or other elongatemember 233. In some embodiments, the shaft or elongate member may bemalleable. Optionally, elongate member 233 may articulate about at leastone joint and/or may be steerable for positioning the system 200.Elongate member may be made of any suitable material, such as metal,ceramic, polymers, or any combination thereof, and may be rigid alongits entire length or rigid in one or more parts and flexible in one ormore parts. In some embodiments, ablation assembly 216, support assembly215, or both, are coupled with or otherwise in operative associationwith actuator assembly 220, optionally via coupling assembly 230.According to some embodiments, the jaw or tubular shaft elements mayinclude a high strength material such as metal, carbon fiber, or thelike.

Clamp assembly 210 may be disposed on or near a distal end 234 ofcoupling assembly 230, and can be generally configured to open and closeto grasp epicardial or other tissue between the opposing jaw mechanisms212, 214. As shown here, actuator assembly 220 is coupled with couplingassembly 230 via a proximal portion 232 of the coupling assembly. Anablation assembly 216 may use any suitable energy source for ablatingtissue. In some embodiments, multiple ablation members may be used in abipolar treatment technique. For example, one electrode (e.g electrode216 a) of a bipolar ablation member may be coupled with one opposing jaw(e.g. distal jaw 214) and another corresponding electrode (not shown)may be coupled with the other opposing jaw (e.g. proximal jaw 212).

Aspects of clamp assembly 210, such as jaw mechanisms 212, 214 orablation assemblies 216, may be shaped to contact and ablate theepicardial tissue in a pattern such as, but not limited to, a U-shapedpattern, an L-shaped pattern, a circular pattern, a nonlinear pattern,or a linear pattern. Actuator assembly 220 may enable the physician toperform one or more various system operations, such as opening andclosing the jaw mechanisms 212, 214, activating an ablation assembly216, changing an angle of orientation of a jaw mechanism 212, 214,straightening or bending a jaw mechanism 212, 214, or the like. Forexample, an actuator assembly may include a trigger-like actuator.Optionally, an actuator assembly may include a turnable dial.

Generally, a jaw mechanism 212, 214 may have any suitable configurationfor contacting a surface of a heart, for grasping epicardial or othertissue to be ablated, for placing ablation members 216 a, 216 b incontact with tissue to be ablated, or for any combination thereof. Assuch, jaw mechanisms 212, 214 may be straight, curved, bent, orotherwise configured for contacting, grasping, or ablating tissue, orany combination thereof.

In some embodiments, jaw mechanisms 212, 214 may be adjustable viaactuator assembly 220, so as to allow their shapes to be bent,straightened, or the like, during a procedure. In some cases, jawmechanisms 212, 214, can be retractable. For example, jaw mechanisms212, 214 may be retracted within coupling assembly 230 upon one or moreoccasions during an operation. Refraction may help protect a patient aswell as a jaw mechanism during insertion and advancement of the systemwithin the patient.

In some embodiments, the treatment system may further include aninsulation member at least partially surrounding or covering one or morethe actuator assembly, coupling assembly, or clamp assembly. Such aninsulation member can operate to protect body structures in the vicinityof the epicardial tissue from being ablated or damaged due to heat orelectrical current. In some cases, ablation members such as electrodes216 a, 216 b may be adjustable to deliver two or more varying amounts ofablative energy to two or more locations on the epicardial tissue.Various embodiments may further include at least one sensor for sensinga quantity of ablation provided by the ablation member to the tissue.

FIG. 3 shows aspects of a treatment system 300 according to embodimentsof the present invention. Treatment system 300 includes a clamp assembly310, an actuator assembly 320, and a coupling assembly 330 in operativeassociation with both the clamp assembly and the actuator assembly.Clamp assembly 310 includes a first jaw mechanism 312 and a second jawmechanism 314. First jaw mechanism 312 is disposed proximal to secondjaw mechanism 314. The jaw mechanisms may include ablation assemblies,as well as support assemblies for holding the ablation assemblies. Forexample, as shown in FIG. 3, second jaw mechanism 314 includes anablation assembly 316 having a proximal electrode 316 a and a distalelectrode 316 b. The proximal and distal electrodes are coupled with asupport assembly 315. First jaw mechanism 312 provides a similarconfiguration, and includes an ablation assembly 317 and a supportassembly 319. The ablation assembly 317 includes a proximal electrode317 a and a distal electrode 317 b that face toward electrodes 316 a,316 b, respectively, of distal jaw mechanism 314. In use, the surgeon oroperator can use the handle or actuator assembly 320 for manipulatingthe treatment system, opening and closing the jaw mechanisms, activatingablation members such as electrodes 316 a, 316 b, 317 a, 317 b, and thelike. Treatment system 300 can be generally configured to be introducedthrough a minimally invasive sheath, trocar, or incision. In some cases,treatment system 300 can be used in open surgical procedures. Couplingassembly 330 may include a shaft or other elongate member 333. In someembodiments, the shaft or elongate member may be malleable. Optionally,elongate member 333 may articulate about at least one joint and/or maybe steerable for positioning the system 300. Elongate member may be madeof any suitable material, such as metal, ceramic, polymers, or anycombination thereof, and may be rigid along its entire length or rigidin one or more parts and flexible in one or more parts. In someembodiments, ablation assemblies 316, 317, support assemblies 315, 319,or any combination thereof, are coupled with or otherwise in operativeassociation with actuator assembly 320, optionally via coupling assembly330.

Clamp assembly 310 may be disposed on or near a distal end 334 ofcoupling assembly 330, and can be generally configured to open and closeto grasp epicardial or other tissue between the opposing jaw mechanism312, 314. An ablation assembly 316 may use any suitable energy sourcefor ablating tissue. In some embodiments, multiple ablation members maybe used in a bipolar treatment technique. For example, one electrode(e.g electrode 316 a) of a bipolar ablation member may be coupled withone opposing jaw (e.g. distal jaw 314) and another correspondingelectrode (e.g. electrode 317 a) may be coupled with the other opposingjaw (e.g. proximal jaw 312). Optionally, ablation assemblies may includeone unipolar ablation device or any of the ablation devices describedelsewhere herein.

Aspects of clamp assembly 310, such as jaw mechanisms 312, 314 orablation assemblies 316, 317 may be shaped to contact and ablate theepicardial tissue in a pattern such as, but not limited to, a U-shapedpattern, an L-shaped pattern, a circular pattern, or a linear pattern.Actuator assembly 320 may enable the physician to perform one or morevarious system operations, such as opening and closing the jawmechanisms 312, 314, activating an ablation assembly 316, 317, changingan angle of orientation of a jaw mechanism 312, 314, straightening orbending a jaw mechanism 312, 314, or the like. For example, an actuatorassembly may include a trigger-like actuator. Optionally, an actuatorassembly may include a turnable dial.

Generally, a jaw mechanism 312, 314 may have any suitable configurationfor contacting a surface of a heart, for grasping epicardial or othertissue to be ablated, for placing ablation members 316 a, 316 b, 317 a,317 b in contact with tissue to be ablated, or for any combinationthereof. As such, jaw mechanisms 312, 314 may be straight, curved, bent,or otherwise configured for contacting, grasping, or ablating tissue, orany combination thereof. In some embodiments, jaw mechanisms 312, 314may be adjustable via actuator assembly 320, so as to allow their shapesto be bent, straightened, or the like, during a procedure. In somecases, jaw mechanisms 312, 314, can be retractable. For example, jawmechanisms 312, 314 may be refracted within coupling assembly 330 uponone or more occasions during an operation. Retraction may help protect apatient as well as a jaw mechanism during insertion and advancement ofthe system within the patient. Ablation members such as electrodes 316a, 316 b, 317 a, 317 b, may be bipolar RF members, unipolar RF members,or any other suitable ablation devices.

In some cases, the tissue treatment systems can have a spring loadedmechanism that allows an indirect connection between the handle and theclamp members or jaws. Hence, during the initial stage of the clampingprocess, there can be a 1:1 ratio between movement of the handle andmovement of the clamp members or jaws. However, during the later stageof the clamping process when the clamp members or jaws are sufficientlyclose to one another, optionally applying sufficient pressure on theatrium, there may not be a 1:1 ratio between movement of the handle andmovement of the clamp members or jaws. Rather, a handle movement resultsin a smaller corresponding movement of the clamp members and jaws. Theablation and monitoring assemblies can be configured as inserts that areremovable with respect to the clamp members or jaws. According to someembodiments, the ablation and monitoring assemblies may be disposable,replaceable, or both, and the clamp or support member can besterilizable, reusable, or both.

According to some embodiments, a treatment system can be convertible;that is, the system can convert from a bipolar configuration tomonopolar configuration and back to a bipolar configuration according tothe surgeon's need or decision. In some cases, a monopolar device doesnot include jaws and can be in the form of a malleable electrode thatpresents a contact strip or surface to deliver RF energy to tissue fromany direction and from any shape it is bent into. In some cases, amonopolar probe resides within or is a part of the handle or shaftstructure of a bipolar clamp. The monopolar electrode can reside in onejaw and act as the active electrode when in a bipolar configuration, andthe other jaw can act as the indifferent (ground) electrode. When thesurgeon converts the device to a monopolar configuration, for example bypulling the monopolar probe assembly out of the rest of the device, theprobe acts as a monopolar device because the return path for energy isnow through the ground pad on the patient. When the surgeon is done withthe monopolar RF application, he or she may choose to straighten theelectrode and reinsert it into the bipolar handle to make that partfunctional again.

In some embodiments, the treatment system may further include aninsulation member at least partially surrounding or covering one or morethe actuator assembly, coupling assembly, or clamp assembly. Such aninsulation member can operate to protect body structures in the vicinityof the epicardial tissue from being ablated or damaged due to heat orelectrical current. In some cases, ablation members such as electrodes316 a, 316 b, 317 a, 317 b may be adjustable to deliver two or morevarying amounts of ablative energy to two or more locations on theepicardial tissue. Various embodiments may further include at least onesensor for sensing a quantity of ablation provided by the ablationmember to the tissue.

Actuator assembly 320 may include a symmetric, unified release trigger.In some cases, the actuator assembly may have a plurality of separatedratchet teeth. In use, the operator or surgeon may close or clamp thejaw mechanisms together by activating a handle or plunger of theactuator assembly. Relatedly, the operator may release the jawmechanisms from a clamped configuration by activating a release triggerof the actuator assembly. In some cases, a release trigger may include abutton or a slide mechanism. The treatment system may be spring loaded,such that release of a ratchet mechanism allows release of the jawmechanisms and the spring allows an automatic position return of theratchet mechanism.

Embodiments of the present invention encompass a variety of mechanismswhich may be used to open or close the jaw mechanisms. In some cases,treatment systems may include a pliers assembly configured to open orclose the jaw mechanisms. In some cases, treatment systems may include ascissors assembly configured to open or close the jaw mechanisms.Optionally, a pliers or scissors assembly can include two members havinga central pivot, whereby the closing of the handle portion closes thedistal portions by changing the angle between the two members fromsomething greater than zero to something less than the starting number,generally bringing together the distal ends. In some cases, treatmentsystems may include a sliding mechanism or assembly configured to openor close the jaw mechanisms. Optionally, the treatment system mayinclude a plunger assembly configured to open or close the jawmechanisms. Exemplary actuator assemblies may include pistol grips,hinged grips, and the like. In some cases, an actuator assembly mayprovide for direct activation or coupling of the jaw mechanisms, suchthat when the surgeon moves a portion of the actuator assembly by agiven amount, the actuator assembly causes the jaw mechanism to move thesame amount in a 1:1 ratio. In some cases, an actuator assembly mayprovide for indirect activation or coupling of the jaw mechanisms, suchthat when the surgeon moves a portion of the actuator by a given amount,the actuator assembly causes the jaw mechanism to move in differingamount. An actuator assembly may be configured to limit, attenuate, oramplify the amount of clamping force applied to a tissue based on theamount of squeezing or activating force manually applied by a surgeon.

In some instances, the treatment system can include a jaw releasetrigger that is symmetric about two planes, and that allows or actuatesrelease of the jaw mechanisms such that the jaw mechanisms translaterelative to each other in an upward or downward manner. Such actuationcan be performed without changing the jaw release finger motion. In somecases, a jaw mechanism release or opening action can be accomplishedwithout changing the operator's basic hand position on the handle. Thesystem can be configured so that the operator can reach or use therelease trigger located in an ergonomically efficient position. Arelease trigger may be self-centering and momentary. In some cases, arelease trigger can have a single re-centering spring that is captive inthe body shell and actuated at either end by a finger that reaches intothe entrapping space from the moving trigger portion from either end tocompress the spring as the trigger is pushed off-center.

FIG. 4 shows a treatment system 400 in a position for performing anablation or treatment procedure on epicardial tissue of heart 440.Treatment system 400 includes a clamp assembly 410 having first andsecond jaw mechanisms 412, 414, and can be configured to ablate in apattern approximating two lines adjacent the right pulmonary veins 442,444. As discussed elsewhere herein, jaw mechanisms 412, 414 can berotated as desired to provide a variety of ablation configurations.Additionally, treatment system 400 may be moved to a variety ofpositions to ablate multiple patterns in multiple locations on theepicardial tissue.

Treatment system 400 includes a handle or actuator assembly 420 disposedtoward a proximal portion of the system. As shown here, first and secondjaw mechanisms 412, 414, which may include two bipolar ablation clamps,are disposed toward a distal portion of the system. The jaw mechanisms412, 414 can be curved or shaped. In some cases, jaw mechanisms 412, 414are curved and adjustably rotatable, so that for each jaw mechanism 412,414, a concave portion or arc of the jaw mechanism can face toward thehandle, away from the handle, toward the right side of the handle,toward the left side of the handle, or toward any desired directionrelative to the handle. In some cases, a jaw mechanism can be inconnectivity with an ablation and monitoring assembly or ESU. Duringuse, the tissue treatment system can be used to contact the cardiactissue, which can be effectively accomplished for example by thecurvature orientation. The curved or contoured shape of the jawmechanisms can allow the treatment system to be placed on the heartwithout impinging upon the pulmonary veins. Hence, there is an increasedlikelihood of ablating tissue of the atrium, as opposed to ablatingtissue of the pulmonary veins themselves. Treatment system 400 is wellsuited for use in surgical methods where access ports are not employed.For example, the treatment system can be inserted into a patient via a3-4 inch thoracotomy. In use, the jaw mechanisms are placed at or nearthe ostia, and actuated until the opposing jaw members are approximately2-5 millimeters apart. This action serves to collapse the atrium nearthe pulmonary veins. An ablation is performed, and the clamping pressureis released thus allowing the atrium to return to the uncompressedstate.

With reference now to FIG. 4A, a method 400 a for ablating cardiactissue, such as epicardial tissue, suitably includes contacting cardiactissue with an ablation device 410 a, securing the device to the tissue420 a and ablating at least a portion of the contacted, secured tissue430 a. Various embodiments can utilize additional steps or sub-steps ofthese three basic steps, although any such any additional steps orvariations are optional. For example, in some embodiments, contactingthe cardiac tissue 410 a can be preceded by advancing the device intothe patient through a minimally invasive introducer device. Contactingthe device with the tissue 410 a may include positioning the deviceusing a positioning arm or other positioning device. In someembodiments, securing the device to the tissue 420 a may also includeinvaginating a portion of epicardial tissue partially within one or moresuction apertures and/or may include using one or more suction aperturesto dissect through fatty tissue disposed over epicardium. Securing thedevice 420 a may also involve securing with enough force to allowstabilization and/or positioning of the heart itself. And ablation ofepicardial tissue 430 a may involve ablation in any location or patternas described elsewhere herein. According to some embodiments, atreatment method 400 a may include imaging tissue with a visualizationdevice 405 a.

Electrosurgical Unit Operation

According to some embodiments, a treatment system may include or becoupled in operative association with an electrosurgical unit (ESU) thatcan supply and control power to an ablation assembly of the treatmentsystem. FIGS. 5, 6A, and 6B illustrate aspects of a treatment system 500that includes or is coupled with an ESU 600 that supplies and controlspower, such RF power, during a treatment procedure. As shown here, ESU600 includes a controller 635, a source of RF power 637 that iscontrolled by the controller, and a plurality of displays and buttonsthat are used to set the level of power supplied to one or moreelectrodes and the temperature at various locations on an electrode. Theexemplary ESU 600 illustrated is operable in a bipolar mode, wheretissue coagulation energy emitted by an electrode 502 is returnedthrough a return electrode 502 a, and a unipolar mode, where the tissuecoagulation energy emitted by the electrode is returned through one ormore indifferent electrodes (not shown) that are externally attached tothe skin of the patient with a patch or one or more electrodes (notshown) that are positioned in the blood pool. The return electrode 502a, which in a bipolar configuration can be identical to the electrode502, may be connected to the ESU 600 by a pair of power return lines 504a and 506 a. The return electrode 502 a and power return lines 504 a and506 a together define a return electrode assembly 500 a.

In some embodiments, return electrode 502 a can be an indifferentelectrode. In a bipolar configuration, an active electrode and anindifferent electrode can cooperate to help form a complete circuit ofRF energy, for example when the two electrodes are placed across ananatomical feature such as the atria or other patient tissue. Energy cantravel from the active electrode through the tissue to the indifferentelectrode. An active electrode can be temperature-controlled, and can becoupled with one or more RF wires and one or more thermocouples. Anindifferent electrode can provide a return path, optionally as a singlewire, operating as a ground. In use, energy passing through theelectrodes can raise the temperature of the intervening tissue, forexample tissue which is secured between two clamp mechanisms. In turn,the heated tissue can raise the temperature of the electrodes. In somecases, active electrodes, indifferent electrodes, or both, can be cooledwith internal cooling mechanisms.

In some instances, a treatment system may include multiple activeelectrodes along a length of a clamp. Each active electrode can becoupled with an RF wire that supplied energy to the electrode, and twothermocouple pairs. A thermocouple pair can include two wires joined bya thermocouple, and the thermocouple can be attached to the electrode,for example at an end portion of the electrode. The thermocouple paircan be used to monitor the temperature of the electrode, or a portion ofthe electrode. In some embodiments, an electrode is coupled with twothermocouple pairs, and the highest of the two temperatures sensed bythe thermocouple pairs can be used to control RF energy delivery to theelectrode.

ESU 600 can be provided with a power output connector 636 and a pair ofreturn connectors 638. The electrode 502 is connected to the poweroutput connector 636 by way of the power supply lines 504 and 506 and apower connector 540, while the return electrode 502 a is connected toone of the return connectors 638 by way of the power return lines 504 aand 506 a and a return connector 542. In some cases, the ESU output andreturn connectors 636 and 638 have different shapes to avoid confusionand the power and return connectors 540 and 542 are correspondinglyshaped. For example, power connector 540 may have a circular shapecorresponding to an ESU power output connector 636 having a circularshape, and return connector 542 may have a rectangular shapecorresponding to an ESU return connector 638 having a rectangular shape.Signals from the temperature sensors 526 a/526 b and 528 a/528 b cantransmitted to the ESU 600 by way of the signal lines 530 and the powerconnector 540.

ESU 600 can be configured to individually power and control a pluralityof electrodes. In some cases, the electrodes may be about 10 mm inlength. Optionally, a bipolar clamp configuration may include two 32 mmactive electrodes and one 70 mm electrode. Such individually powered orcontrolled configurations may be referred to as providing “multi-channelcontrol.” In some cases, ESU 600 can include up to 8 channels, or more.ESU 600 can also be configured to individually power and control two ormore portions of a single electrode as well as two or more portions ofeach of a plurality of electrodes during a lesion formation procedure.Electrode 502 as shown here can be divided into two portions for powercontrol purposes. The electrode portion connected to the power supplyline 504 on one side of the dash line in FIG. 6A and the electrodeportion connected to the power supply line 506 on the other side of thedash line. According to some embodiments, the dash line does notrepresent a physical division and the electrode 502 is a continuous,unitary structure. Electrode 502 can be placed adjacent to tissue andpower to one portion can be controlled by control channel CH1 and powerto the other portion is controlled by control channel CH2. The power canbe, although not necessarily, supplied to both portions simultaneously.Aspects of exemplary power supply/lesion formation methods areillustrated in FIG. 7.

According to some embodiments, the level of power supplied to theelectrode 502 by way of the power supply line 504 may be controlledbased on the temperatures sensed by the temperature sensors 526 a/526 b,while the level of power supplied to the electrode 502 by way of thepower supply line 506 may be controlled based on the temperatures sensedby the temperature sensors 528 a/528 b. In one exemplary control scheme,the level of power supplied to the electrode 502 by way of the powersupply line 504 can be controlled based on the highest of the twotemperatures sensed by the temperature sensors 526 a/526 b, while thelevel of power supplied to the electrode 502 by way of the power supplyline 506 can be controlled based on the highest of the two temperaturessensed by the temperature sensors 528 a/528 b.

The amount of power required to coagulate tissue typically ranges from 5to 150 w. Aspects of suitable temperature sensors and power controlschemes that are based on sensed temperatures are disclosed in U.S. Pat.Nos. 5,456,682, 5,582,609 and 5,755,715, the contents of which areincorporated herein by reference.

The actual number and location of the temperature sensors may be variedin order to suit particular applications. As illustrated for example inFIG. 6B, the temperature sensors 528 a and 528 b may be located on thereturn electrode 502 a in certain bipolar implementations. Optionally,the power control scheme can be the same in that the level of powersupplied to the electrode 502 by way of the power supply line 504 can becontrolled based on the temperatures sensed by the temperature sensors526 a/526 b, while the level of power supplied to the electrode 502 byway of the power supply line 506 can be controlled based on thetemperatures sensed the temperature sensors 528 a/528 b.

According to some embodiments, a plurality of spaced electrodes can beprovided that operate in a unipolar mode. Each of the electrodes can beconnected to a respective pair of power supply lines and include its ownset of temperature sensors. Each of the electrodes on a surgical probecan be divided into portions for power control purposes, and the levelof power supplied to some electrode portions by way of power supplylines can be controlled based on the temperatures sensed by certaintemperature sensors, while the level of power supplied to otherelectrode portions by way of power supply lines can be controlled basedon the temperatures sensed by certain other temperature sensors.

Articulating and Adjustable Clamp Mechanisms

Embodiments of the present invention provide multiple approaches foractuating clamp mechanism components, such that clamp jawbones can berotated and locked into various useful angular orientations orpositions. Typically, the jawbones are rigid with a fixed curve orshape, which allow a surgeon to easily adjust a treatment profiledelivered by the treatment system. For example, the jawbones can berotated to an orientation suitable for clamping across the base of apulmonary vein (PV) or across the base of multiple pulmonary veins. Theclamp mechanisms may operate to “bite” into the patient tissue. In theinstance where pulmonary veins extend from the left atrium, the curve ofthe clamp mechanisms can be rotatably adjusted so that the outward orconvex curve presented by the clamps is opposite the base curvature thepulmonary vein or atrial chamber wall. In some cases, the veins can berelatively short and straight, having no base curvature to them, andexit the atria somewhat perpendicularly to the surface of the atria.Hence, the clamp mechanisms can be used not only pinch the base of thepulmonary vein, but also to “bite” into or beyond the base of the vein,such as to clamp portions of the atrial walls together. The rotatablyadjustable nature of the treatment system jawbones allows the surgeon toconfigure the clamping mechanism in an orientation appropriate for thedirection or route in which the system is introduced to the treatmentsite.

Pull and Rotate Embodiments

FIG. 8A depicts aspects of an adjustable clamp system 800 a according toembodiments of the present invention. As shown here, clamp system 800 aincludes a clamp assembly 810 a coupled with or in operative associationwith a base assembly 820 a. Clamp assembly 810 a has a first jawmechanism 812 a and a second jaw mechanism 814 a, and base assembly 820a has a first base mechanism 830 a and a second base mechanism 840 a.First jaw mechanism 812 a is coupled with first base mechanism 830 a,and second jaw mechanism 814 a is coupled with second base mechanism 840a. In use, first and second base mechanisms 830 a, 840 a are translatedrelative to one another, as indicated by arrow A, which in turn causesfirst jaw mechanism 812 a and second jaw mechanism 814 a to move awayfrom or toward one another, as indicated by arrow B. According to someembodiments, first base mechanism 830 a may include a first base 832 acoupled with a first base shaft element 834 a. Relatedly, second basemechanism 840 a can include a second base 842 a coupled with a secondbase shaft element 844 a. As depicted here, second base shaft element844 a includes a groove 846 a that is configured to receive a tongue 833a of first base 832 a. In some cases portion 832 a forms a part of thejaw base. It can be a blended curved shape that gives stiffness to thejaw and an appropriate length to join the base to the shaft, for exampleby a laser weld. Further, each of the first and second jaw mechanismsmay include a flexible boot coupled with a flexible ablation member, andoptionally an end plug mechanism. For example, first jaw mechanism 812 amay include a flexible boot 811 a coupled with a flexible ablationmember (not shown) and an end plug mechanism 816 a. Relatedly, secondjaw mechanism 814 a may include a flexible boot 813 a coupled with aflexible ablation member 817 a and an end plug mechanism 818 a.According to exemplary embodiments, each of the jaw mechanisms mayinclude a jawbone mechanism (not shown) disposed at least partiallywithin the flexible boot. Such jawbones may be configured to rotate orrevolve within or relative to the respective boots 811 a, 813 a, forexample. In some cases, the jawbones may rotate within the boots, whileflexible electrode mounting surfaces 817 a, 819 a of boots 811 a, 813 a,respectively, remaining facing one another. According to someembodiments, the jawbones do not rotate around while the electrodes arein use. Typically, the boots take on the shape of the backbone within.

End plug mechanisms 816 a, 818 a may include any of a variety ofauxiliary elements, including lights, cameras, sensors, fluid passages,nozzle features, knobs, and the like. Relatedly, end plug mechanisms 816a, 818 a can be used by a physician or operator to perform varioussurgical techniques. For example, one or both of end plug mechanisms 816a, 818 a can include a tissue plane dissector. In some cases, one orboth of end plug mechanisms 816 a, 818 a can include an introducertubing mount or other navigational mechanism, and hence can be used inconjunction with introducer or navigational systems, such as thosedescribed in U.S. patent application Ser. Nos. 12/124,743 and 12/124,766filed May 21, 2008, U.S. patent application Ser. No. 12/339,331 filedDec. 19, 2008, U.S. Provisional Patent Application No. 61/179,564 filedMay 19, 2009, and U.S. Provisional Application No. 61/241,297 filed Sep.10, 2009, the entire content of each of which is incorporated herein byreference. In some case, one or both of end plug mechanisms 816 a, 818 acan include a light mechanism. Optionally, one or both of end plugmechanisms 816 a, 818 a can include a camera or video mechanism.According to some embodiments, one or both of end plug mechanisms 816 a,818 a can include a cooling water or fluid passage terminal. In somecases, one or both of end plug mechanisms 816 a, 818 a can include aflush, dissection, or insufflation nozzle. Optionally, one or both ofend plug mechanisms 816 a, 818 a can include one or more sensors formultiple applications. According to some embodiments, one or both of endplug mechanisms 816 a, 818 a can include a manual knob for rotating aninternal jawbone. In some cases, a treatment system may present adisposable dedicated bipolar clamp having flip jaw revolving or rotaryjawbones disposed at least partially within a flexible electrode boot.Embodiments also include system configurations having jaws withclosed-end boots and no end plugs.

FIG. 8B depicts aspects of an adjustable clamp system 800 b according toembodiments of the present invention. As shown here, clamp system 800 bincludes a clamp assembly 810 b coupled with or in operative associationwith a base assembly 820 b. Clamp assembly 810 b has a first jawmechanism 830 b and a second jaw mechanism 860 b, and base assembly 820b has a first base mechanism 850 b and a second base mechanism 880 b.First jaw mechanism 830 b can be coupled with first base mechanism 850 bvia a first rotational assembly 840 b and second jaw mechanism 860 b canbe coupled with second base mechanism 880 b via a second rotationalassembly 870 b. In some embodiments, one or more elements of firstrotational assembly 840 b are part of or integral to first basemechanism 850 b. In some embodiments, one or more elements of firstrotational assembly 840 b are part of or integral to first jaw mechanism830 b. In some embodiments, one or more elements of second rotationalassembly 870 b are part of or integral to second base mechanism 880 b.In some embodiments, one or more elements of second rotational assembly870 b are part of or integral to second jaw mechanism 860 b.

First jaw mechanism 830 b includes an internal jawbone 832 b that canrotate within a flexible boot 834 b. Similarly, second jaw mechanism 860b includes an internal jawbone 862 b that can rotate within a flexibleboot 864 b. The flexible boots 834 b, 864 b are coupled with basemechanisms 850 b, 880 b, respectively. Hence, each internal jawbone canrotate relative to its respective boot and base mechanism, while theboot and base mechanism remain rotationally stationary with regard toone another. However, the internal jawbones can be shaped so that thethree dimensional interface configuration between the boots changes asthe jawbones rotate. In the illustration provided by FIG. 8B, theflexible boots 834 b, 864 b are shown in a transparent view, so as todepict the relationship between internal components such as therespective jawbones 832 b, 862 b.

In some embodiments, the term “jawbone” may be used interchangeably withthe term “guide.” Relatedly, in some embodiments a jaw mechanismincludes a guide that can rotate within or relative to an ablationapparatus having an ablation member or electrode. An ablation apparatus,ablation member, or electrode can be coupled with a base mechanism. Theguide can rotate relative to its corresponding ablation apparatus orelectrode, and can also rotate relative to its corresponding basemechanism. During such rotation of the guide, the ablation apparatus orelectrode and the base mechanism can remain rotationally stationary withregard to one another. Guides can be shaped so that the threedimensional interface configuration between their respective ablationapparatuses or electrodes can change or rotate as the guides rotate. Insome cases, clamp systems are configured so that the three dimensionalinterface configuration between ablation apparatuses or electrodes canbe adjustably fixed or set at desired angles or orientations. The threedimensional interface configuration can be defined by the alignmentbetween the ablation apparatuses or electrodes. In some cases, theablation apparatuses or electrodes can be present in a curved parallelrelationship, in that the longitudinal axes of the ablation apparatusesor electrodes do not intersect, and are aligned at a constant or fixeddistance from each other along their length. During actuation, thedistance between two electrodes can decrease as the clamp system isclamped and increase as the clamp system is unclamped.

First rotational assembly 840 b allows internal jawbone 832 b toadjustably rotate relative to base mechanism 850 b and boot 834 b. Forexample, first rotational assembly 840 b may include a jawbone collar842 b within which jawbone 832 b may adjustably revolve, as indicated byarrow A. Similarly, second rotational assembly 870 b may include ajawbone collar 872 b within which jawbone 862 b may adjustably revolve,as indicated by arrow B. As shown here, second jawbone 862 b may includeor be coupled with a pin 874 b of second rotational assembly 870 b thattranslates along and within a slot 875 b of collar 872 b or basemechanism 880 b as indicated by arrow C, thus causing compression orallowing decompression of a compressible member 876 b of rotationalassembly 870 b. Compressible member 876 b may include a spring, anelastomeric material, or any other suitable compressible element. Thejawbones can be constructed of a rigid material, and as such, thejawbone shape can provide a guiding support or skeletal framework forthe shape of the flexible boots.

FIG. 8C depicts aspects of an adjustable clamp system 800 c according toembodiments of the present invention. As shown here, clamp system 800 cincludes a clamp assembly 810 c coupled with or in operative associationwith a base assembly 820 c. Clamp assembly 810 c has a first jawmechanism 830 c, and base assembly 820 c has a first base mechanism 850c. First jaw mechanism 830 c can be adjustably coupled with first basemechanism 850 c, optionally via a first rotational assembly 840 c. Insome embodiments, one or more elements of first rotational assembly 840c are part of or integral to first base mechanism 850 c. In someembodiments, one or more elements of first rotational assembly 840 c arepart of or integral to first jaw mechanism 830 c. First jaw mechanism830 c includes an internal jawbone 832 c that can rotate within aflexible boot (not shown). The flexible boot can be coupled with basemechanism 850 c. Hence, internal jawbone 832 c can rotate relative tobase mechanism 850 c, while the boot and base mechanism remainrotationally stationary with regard to one another.

First rotational assembly 840 c, or optionally base mechanism 850 c,allows internal jawbone 832 c to adjustably rotate relative to basemechanism 850 c and a boot (not shown). For example, first rotationalassembly 840 c or base mechanism 850 c may include a jawbone collar 842c within which jawbone 832 c may adjustably revolve, as indicated byarrow A. As shown here, first jawbone 832 c may include or be coupledwith a pin 844 c of first rotational assembly 840 c that translatesalong or sets within a slot or pocket 845 c of collar 842 c or basemechanism 850 c as indicated by arrow C, thus causing compression orallowing decompression of a compressible member 846 c, which may be apart of jawbone 832 c, rotational assembly 840 c, or base mechanism 850c.

A compressible member may include a spring, an elastomeric material, orany other suitable compressible element or combination of elements. Insome cases, a compressible member or assembly includes one or morerebounding members such as springs, elastomers, elasticized members, andthe like. A spring can be defined as a flexible elastic object which canstore potential or mechanical energy. Exemplary springs include coilsprings, helical springs, conical springs, torsion springs, volutesprings, gas springs, and the like. Typically, a compression springbecomes shorter when subjected to a load. In some cases, a compressiblemember can include an elastomeric or rubber material. An elastomer canrefer to a polymer which resists and recovers from deformation which isproduced by a force applied to the polymer. Typically, an elastomerbecomes shorter or compressed when subjected to a load. An elastomer mayreturn to its original dimensions after being deformed under anapplication of mechanical force. In some cases, the terms “elastomer”and “rubber” are used interchangeably, and can refer to natural orsynthetic materials, or combinations thereof. An elastomer can be aflexible elastic object which can store potential or mechanical energy.Different elastomers may have different durometers or compressibilities.For example, a first elastomer may have a lower durometer, or a highercompressibility, than a second elastomer. Often, a durometer value orrating is inversely related to a compressibility value or rating. Adurometer rating can be a measure of the resistance a material exhibitsto deformation. For example, a material having a high durometer, or alow compressibility, may exhibit a greater resistance to deformationwhen subjected to a load or stress. An elastomer can have a linearcompressibility, where the compressibility is constant or substantiallyconstant regardless of the load applied to the elastomer. An elastomermay also have a progressive compressibility, where the compressibilityof the elastomer changes as an increasing load is applied to theelastomer.

In use, an operator may adjust the rotational position of internaljawbone 832 c by pulling or moving jawbone 832 c in a distal direction,as indicated by arrow D, thus compressing the compressible member 846 cand drawing pin 844 c out or away from pocket 845 c. Once the pin issufficiently withdrawn from the pocket, the operator can rotate jawbone832 c as indicated by arrow A. Base mechanism 850 c or rotationalassembly 840 c may include a plurality of pockets into which pin 844 cmay fit. Hence, for example, when the operator has rotated jawbone 832 cto the desired rotational configuration, the operator may release orreduce the pulling or moving force applied to jawbone 832 c, thusallowing compressible member 846 c to decompress as pin 844 c movesproximally into the appropriate pocket in a direction illustrated byarrow E. Compressible member 846 c can therefore operate to urge thepin, and consequently the jawbone, in a proximal direction. When pin 844c is disposed within the pocket, compressible member 846 c can operateto prevent or inhibit jawbone 832 c from moving in a distal direction.In this way, pin 844 c remains in the pocket, thus restraining furtherrotational movement of jawbone 832 c. Hence, the operator can securely,and releasably, fix the jawbone in an orientation that is optimal fortreating a desires anatomical shape or feature. As shown here, baseassembly 820 c includes a mousehole 822 c through which energytransmission wires, temperature sensor wires, fluid conduits, and thelike, can be routed to and from the jaw mechanism. For example, anactive electrode on a clamp may be attached with an RF wire and fourthermocouple wires (e.g. two thermocouple pairs each having twothermocouple wires), an indifferent electrode may be attached with areturn wire. In this case, any or all of the six wires can be routedthrough the mousehole.

FIG. 8D depicts aspects of an adjustable clamp system 800 d according toembodiments of the present invention. As shown here, clamp system 800 dincludes a clamp assembly 810 d coupled with or in operative associationwith a base assembly 820 d. Clamp assembly 810 d has a first jawmechanism 830 d, and base assembly 820 d has a first base mechanism 850d. First jaw mechanism 830 d can be adjustably coupled with first basemechanism 850 d, optionally via a first rotational assembly 840 d. Insome embodiments, one or more elements of first rotational assembly 840d are part of or integral to first base mechanism 850 d. In someembodiments, one or more elements of first rotational assembly 840 d arepart of or integral to first jaw mechanism 830 d. First jaw mechanism830 d includes an internal jawbone 832 d that can rotate within aflexible boot 834 d. The flexible boot can be coupled with basemechanism 850 d or rotational assembly 840 d, or both. Hence, internaljawbone 832 d can rotate relative to base mechanism 850 d, while boot834 d and base mechanism 850 d remain rotationally stationary withregard to one another.

Base mechanism 850 d, optionally in combination with first rotationalassembly 840 d, allows internal jawbone 832 d to adjustably rotaterelative to base mechanism 850 d and boot 834 d. For example, firstrotational assembly 840 d or base mechanism 850 d may include a jawbonecollar 842 d within which jawbone 832 d may adjustably revolve, asindicated by arrow A. As shown here, first jawbone 832 d may include orbe coupled with a pin 844 d that translates along or sets within a stopor pocket 843 d of collar of base assembly 820 d as indicated by arrowC, thus causing compression or allowing decompression of a compressiblemember 846 d, which may be a part of jawbone 832 d, rotational assembly840 d, or base mechanism 850 d.

In use, an operator may adjust the rotational position of internaljawbone 832 d by pulling or moving jawbone 832 d in a distal direction,as indicated by arrow D, thus compressing the compressible member 846 dand moving pin 844 d away from stop 845 d. Such action causes a proximalportion 847 d of the compressible member to move toward a distal portion849 d of the compressible member. Once the pin is moved to predetermineddistance away from the stop, the operator can rotate jawbone 832 d asindicated by arrow A. Base assembly 820 d or rotational assembly 840 dmay include a plurality of stops or pockets into which pin 844 d mayfit. Hence, for example, when the operator has rotated jawbone 832 d tothe desired rotational configuration, the operator may release or reducethe pulling or moving force applied to jawbone 832 d, thus allowingcompressible member 846 d to decompress as pin 844 d moves proximallyinto the appropriate pocket in a direction as indicated by arrow E. Whenpin 844 d is disposed within the pocket, compressible member 846 d canoperate to prevent or inhibit jawbone 832 d from moving in a distaldirection. In this way, pin 844 d remains in the pocket, thusrestraining further rotational movement of jawbone 832 d.

FIG. 8E depicts aspects of an adjustable clamp system 800 e according toembodiments of the present invention. As shown here, clamp system 800 eincludes a clamp assembly 810 e coupled with or in operative associationwith a base assembly 820 e. Clamp assembly 810 e has a first jawmechanism 830 e, and base assembly 820 e has a first base mechanism 850e. First jaw mechanism 830 e can be adjustably coupled with first basemechanism 850 e, optionally via a first rotational assembly 840 e. Insome embodiments, one or more elements of first rotational assembly 840e are part of or integral to first base mechanism 850 e. In someembodiments, one or more elements of first rotational assembly 840 e arepart of or integral to first jaw mechanism 830 e. First jaw mechanism830 e includes an internal jawbone 832 e that can rotate within aflexible boot 834 e. The flexible boot can be coupled with basemechanism 850 e or rotational assembly 840 e, or both. Hence, internaljawbone 832 e can rotate relative to base mechanism 850 e, while boot834 e and base mechanism 850 e remain rotationally stationary withregard to one another. Optionally, boot 834 e and base mechanism 850 emay be coupled via one or more attachment points or locations 835 e. Forexample, the boot may be glued or fixed to the base mechanism via anadhesive or other attachment mechanism.

First rotational assembly 840 e, optionally in combination with basemechanism 850 e or base assembly 820 e, allows internal jawbone 832 e toadjustably rotate relative to base mechanism 850 e or base assembly 820e and boot 834 e. For example, first rotational assembly 840 e or basemechanism 850 e, or a combination thereof, may provide a jawbone channel843 e within which jawbone 832 e may adjustably revolve, as indicated byarrow A. As shown here, first jawbone 832 e may include or be coupledwith a pin 844 e that translates along or sets within a stop or pocket845 e of channel 843 e as indicated by arrow C, thus causing compressionor allowing decompression of a compressible member 846 e, which may be apart of jawbone 832 e, rotational assembly 840 e, or base mechanism 850e.

In use, an operator may adjust the rotational position of internaljawbone 832 e by pulling or moving jawbone 832 e in a distal direction,as indicated by arrow D, thus compressing the compressible member 846 ebetween stop 852 e and pin 844 e, where stop 852 e is fixed relative tobase mechanism 850 e. This compression or pulling action operates tomove pin 844 e away from stop 845 e, which may also be fixed relative tobase mechanism 850 e. As shown here, the pin remains stationary relativeto the body of the jawbone. Once the pin is moved to a predetermineddistance away from the stop 845 e, such that the jawbone is translatedalong its long axis as indicated by arrow D, the operator can rotatejawbone 832 e as indicated by arrow A. Base mechanism 850 e orrotational assembly 840 e may include a plurality of stops or pocketsinto which pin 844 e may fit. Hence, for example, when the operator hasrotated jawbone 832 e to the desired rotational configuration, theoperator may release or reduce the pulling or moving force applied tojawbone 832 e, thus allowing compressible member 846 e to decompress aspin 844 e moves proximally as indicated by arrow E into the appropriatepocket. For example a compressible member or spring can operate to forcethe pin into or toward the pocket. When pin 844 e is disposed within thepocket, compressible member 846 e can operate to prevent or inhibitjawbone 832 e from moving in a distal direction. In this way, pin 844 eremains in the pocket, thus restraining further rotational movement ofjawbone 832 e. Hence, the pin and pocket can be part of ananti-rotational feature or assembly that counters rotational momentswhen clamping forces are applied to the clamp mechanism.

FIG. 8F illustrates aspects of a treatment system 800 f according toembodiments of the present invention. As shown here, a jawbone member832 f can adjustably rotate relative to a base assembly 820 f asindicated by arrow A. Jawbone member 832 f includes one or more pins orprotrusions 844 f, and the base assembly includes one or more pockets orstops 843 f that are configured to receive a jawbone pin. When pin 844 fis disengaged from stop 843 f, the jawbone can rotate relative to thebase assembly as indicated by arrow A. When pin 844 f is engaged with orsecured by stop 843 f, the jawbone is prevented or inhibited fromrotating relative to the base assembly.

FIG. 8G illustrates aspects of a treatment system 800 g according toembodiments of the present invention. Treatment system 800 g includes aclamp assembly 810 g, an actuator assembly 820 g, and a couplingassembly 830 g in operative association with both the clamp assembly andthe actuator assembly. Clamp assembly 810 g includes a first jawmechanism 812 g and a second jaw mechanism 814 g. Coupling assembly 830g may include a shaft or other elongate member that allows the physicianor operator to access or reach a surgical site with the clamp assembly,when the physician is holding actuator assembly 820 g. Coupling assembly830 g includes a proximal end 832 g and a distal end 834 g. As shownhere, clamp assembly 810 g is coupled with distal end 834 g of couplingassembly 830 g, and actuator assembly 820 g is coupled with proximal end832 g of coupling assembly 830 g. Clamp assembly 810 g is depicted in agenerally open configuration, such that first jaw mechanism 812 g doesnot contact or is situated at a distance from second jaw mechanism 814g. The treatment system includes a serpentine electrode or ablationmember 815 g disposed on second jaw mechanism 814 g. The first jawmechanism 812 g includes a corresponding electrode or ablation member(not shown) that faces toward ablation member 815 g. In use, when thejaw mechanisms are clamped together, the respective ablation members ofthe first and second jaw mechanisms contact the surface of the tissue T.First jaw mechanism 812 g includes a distal tip 811 g, and second jawmechanism includes a distal tip 813 g. FIG. 8G illustrates aspects of atreatment system that is configured in an “up curve” orientation. Thatis, when the actuator handle 820 g is held by the surgeon, with thedevice shaft 830 g extending horizontally away from the surgeon's bodyand the jawbone tips 811 g, 813 g pointed in an upward direction, theclamp mechanisms 812 g, 814 g are curved or arced toward the handle 820g or operator, such that concave or inner faces or portions 816 g, 817g, respectively, of the jawbones or jaw mechanisms 812 g, 814 g facetoward the handle or operator in the direction indicated by arrow A, andconvex or outer faces or portions 818 g, 819 g, respectively, of thejawbones or jaw mechanisms 812 g, 814 g face away from the handle oroperator in the direction indicated by arrow B. In some cases, the terminner faces refers to the surfaces that face each other where theelectrodes are mounted. The device can also present an inner or insidespace between the jaws, which can be defined by an inside measurementbetween the jaws.

FIG. 8H illustrates aspects of a treatment system 800 h according toembodiments of the present invention. Treatment system 800 h includes aclamp assembly 810 h, an actuator assembly 820 h, and a couplingassembly 830 h in operative association with both the clamp assembly andthe actuator assembly. Clamp assembly 810 h includes a first jawmechanism 812 h and a second jaw mechanism 814 h. Coupling assembly 830h may include a shaft or other elongate member that allows the physicianor operator to access or reach a surgical site with the clamp assembly,when the physician is holding actuator assembly 820 h. Coupling assembly830 h includes a proximal end 832 h and a distal end 834 h. As shownhere, clamp assembly 810 h is coupled with distal end 834 h of couplingassembly 830 h, and actuator assembly 820 h is coupled with proximal end832 h of coupling assembly 830 h. Clamp assembly 810 h is depicted in agenerally open configuration, such that first jaw mechanism 812 h doesnot contact or is situated at a distance from second jaw mechanism 814h. The treatment system includes a serpentine electrode or ablationmember 815 h disposed on second jaw mechanism 814 h. The first jawmechanism 812 h includes a corresponding electrode or ablation member(not shown) that faces toward ablation member 815 h. In use, when thejaw mechanisms are clamped together, the respective ablation members ofthe first and second jaw mechanisms contact the surface of the tissue T.First jaw mechanism 812 h includes a distal tip 811 h, and second jawmechanism includes a distal tip 813 h. FIG. 8H illustrates aspects of atreatment system that is configured in an “down curve” orientation. Thatis, when the actuator handle 820 h is held by the surgeon, with thedevice shaft 830 h extending horizontally away from the surgeon's bodyand the jawbone tips 811 h, 813 h pointed in an upward direction, theclamp mechanisms 812 h, 814 h are curved or arced away from the handle820 h or operator, such that such that concave or inner faces orportions 816 h, 817 h, respectively, of the jawbones or jaw mechanisms812 h, 814 h face away from the handle 820 h or operator in thedirection indicated by arrow A, and convex or outer faces or portions818 h, 819 h, respectively, of the jawbones or jaw mechanisms 812 h, 814h face toward the handle 820 h or operator in the direction indicated byarrow B.

FIG. 8I illustrates aspects of a treatment system 800 i according toembodiments of the present invention. Treatment system 800 i includes aclamp assembly 810 i, an actuator assembly 820 i, and a couplingassembly 830 i in operative association with both the clamp assembly andthe actuator assembly. Clamp assembly 810 i includes a first jawmechanism 812 i and a second jaw mechanism 814 i. Coupling assembly 830i may include a shaft or other elongate member that allows the physicianor operator to access or reach a surgical site with the clamp assembly,when the physician is holding actuator assembly 820 i. Coupling assembly830 i includes a proximal end 832 i and a distal end 834 i. As shownhere, clamp assembly 810 i is coupled with distal end 834 i of couplingassembly 830 i, and actuator assembly 820 i is coupled with proximal end832 i of coupling assembly 830 i. Clamp assembly 810 i is depicted in agenerally open configuration, such that first jaw mechanism 812 i doesnot contact or is situated at a distance from second jaw mechanism 814i. The treatment system includes a serpentine electrode or ablationmember 815 i disposed on second jaw mechanism 814 i. The first jawmechanism 812 i includes a corresponding electrode or ablation member(not shown) that faces toward ablation member 815 i. In use, when thejaw mechanisms are clamped together, the respective ablation members ofthe first and second jaw mechanisms contact the surface of the tissue T.First jaw mechanism 812 i includes a distal tip 811 i, and second jawmechanism includes a distal tip 813 i. FIG. 8I illustrates aspects of atreatment system that is configured in a “right curve” orientation. Thatis, when the actuator handle 820 i is held by the surgeon, with thedevice shaft 830 i extending horizontally away from the surgeon's bodyand the jawbone tips 811 i, 813 i pointed in an upward direction, theclamp mechanisms 812 i, 814 i are curved or arced toward the right, suchthat concave or inner faces or portions 816 i, 817 i, respectively, ofthe jawbones or jaw mechanisms 812 i, 814 i face toward the right in thedirection indicated by arrow A, and convex or outer faces 818 i, 819 i,respectively, of the jawbones or jaw mechanisms 812 i, 814 i face towardthe left in the direction indicated by arrow B.

FIG. 8J illustrates aspects of a treatment system 800 j according toembodiments of the present invention. Treatment system 800 j includes aclamp assembly 810 j, an actuator assembly 820 j, and a couplingassembly 830 j in operative association with both the clamp assembly andthe actuator assembly. Clamp assembly 810 j includes a first jawmechanism 812 j and a second jaw mechanism 814 j. Coupling assembly 830j may include a shaft or other elongate member that allows the physicianor operator to access or reach a surgical site with the clamp assembly,when the physician is holding actuator assembly 820 j. Coupling assembly830 j includes a proximal end 832 j and a distal end 834 j. As shownhere, clamp assembly 810 j is coupled with distal end 834 j of couplingassembly 830 j, and actuator assembly 820 j is coupled with proximal end832 j of coupling assembly 830 j. Clamp assembly 810 j is depicted in agenerally open configuration, such that first jaw mechanism 812 j doesnot contact or is situated at a distance from second jaw mechanism 814j. The treatment system includes a serpentine electrode or ablationmember 815 j disposed on second jaw mechanism 814 j. The first jawmechanism 812 j includes a corresponding electrode or ablation member(not shown) that faces toward ablation member 815 j. In use, when thejaw mechanisms are clamped together, the respective ablation members ofthe first and second jaw mechanisms contact the surface of the tissue T.First jaw mechanism 812 j includes a distal tip 811 j, and second jawmechanism includes a distal tip 813 j. FIG. 8J illustrates aspects of atreatment system that is configured in a “left curve” orientation. Thatis, when the actuator handle 820 j is held by the surgeon, with thedevice shaft 830 j extending horizontally away from the surgeon's bodyand the jawbone tips 811 j, 813 j pointed in an upward direction, theclamp mechanisms 812 j, 814 j are curved or arced toward the left, suchthat concave or inner faces or portions 816 j, 817 j, respectively, ofthe jawbones or jaw mechanisms 812 j, 814 j face toward the left in thedirection indicated by arrow A, and convex or outer faces 818 j, 819 j,respectively, of the jawbones or jaw mechanisms 812 j, 814 j face towardthe right in the direction indicated by arrow B.

As illustrated by FIGS. 8G-8J, a single treatment system can be used todeliver an ablation treatment at a variety of treatment planes orconfigurations in three dimensions. As the jawbones are rotatablyadjusted throughout their range of motion, the corresponding line orzone of ablation that is created or defined between the clamp electrodesis rotated as well. Thus, for example, during the course of a medicaltreatment a surgeon can use the system to deliver a “right curve”ablation, change the orientation of the jawbones, and then use the samesystem to deliver a “left curve” ablation, or an “up curve” or “downcurve” ablation.

As shown in FIG. 8K, a jawbone 800 can be rotated or flipped about itslong axis, to a predetermined angular orientation (e.g. 0°, 90°, 180°,or 270°). As the jawbone rotates throughout the angular range, the shapeof the boot and electrode may flex and conform with the underlyingconfiguration of the jawbone, however the angular orientation of theboot and electrode is unchanged. In this way, opposing electrodes onseparate jaw mechanisms remain facing toward one another, suitable foradministering treatment to a tissue that may be clamped therebetween. Asshown here, the 0° position corresponds to the configuration where theconcave side of the jawbone faces toward the handle, as indicated byarrow A. Relatedly, the 90° position corresponds to the configurationwhere the concave side of the jawbone faces toward the right, relativeto the longitudinal axis 820 of the shaft 810 as viewed from a proximalportion 822 of longitudinal axis 820, as indicated by arrow B. The 180°position corresponds to the configuration where the concave side of thejawbone faces away from the handle, as indicated by arrow C. Further,the 270° position corresponds to the configuration where the concaveside of the jawbone faces toward the left, relative to the longitudinalaxis 820 of the shaft 810 as viewed from a proximal portion 822 oflongitudinal axis 820, as indicated by arrow D.

Typically, the jawbones are rigid with a fixed curve or shape. Suchrotatable curved jawbones allow the surgeon or operator to easily adjustthe treatment profile of the ablation system. In some cases, the surgeoncan adjust the rotation of the jawbones to a desired orientation fortreating the left atrium, which presents a hemispherical shape.Optionally, the jawbones can be rotated to an orientation suitable forclamping across the base of a pulmonary vein (PV) or across the base ofmultiple pulmonary veins. In some cases, the clamp mechanisms operate to“bite” into the patient tissue, for example into the left atrial tissue,without completely wrapping around or encircling the tissue oranatomical feature. In the instance where four pulmonary veins extendfrom the left atrium, the curve of the clamp mechanisms can be rotatablyadjusted so that the curve presented by the clamps is opposite the atriaor the base curvature of one or more pulmonary veins. Hence, the clampmechanisms can be actuated by the surgeon to not only pinch the base ofthe pulmonary veins, but also to “bite” into the base, such that theclamp mechanisms operate to clamp portions of the atrial walls together,instead of or in addition to clamping portions of the valves or veinstogether. In some cases, a surgeon or operator may find it is easier ormore convenient to approach a treatment site from a particulardirection. For example, the surgeon may desire to approach a tissuetreatment site from above the site, from below the site, or from theright, left, front, or back of the site, and the like. The rotatablyadjustable nature of the treatment system jawbones allows the surgeon toconfigure the clamping mechanism in an orientation appropriate for thetissue shape as well as for the direction or approach in which thesystem is introduced to the treatment site. Moreover, the same systemcan be adjusted in various orientations according to the particular sitetreated or the approach taken by the surgeon. Embodiments of the presentinvention are well suited for use in creating an endocardial/epicardialablation during a stopped-heart procedure. For example, the procedurecan be performed with a curved position of one jaw inside and the otheroutside the atrial wall.

In this way, the treatment system can be configured for delivering ashaped ablation to a right pulmonary vein or a left pulmonary vein. Insome cases, the jaw mechanisms can be oriented for delivering aconnecting lesion to tissue of an organ or appendage. By rotating thejawbones to the desired angular position the surgeon is enabled to clamptissue, and deliver treatment having a stable or persistent curvedablation profile, due to the structural rigidity of the jaw mechanisms.Relatedly, the operator can administer a significant amount of clampingforce to the jaw mechanisms, without causing the jawbones to flex. Therigid jawbones maintain their alignment or orientation relative to oneanother when subjected to high clamping forces, thus ensuring aneffective and efficient ablation produced by electrodes disposed on thejaw mechanisms. In this way, the rigid jawbones, optionally incombination with the anti-rotational features, can help the system toresist or inhibit rotational moments that may be introduced whenclamping forces are applied.

As the jawbone rotates or flips about its long axis, the jawbone deformsor alters the shape of the boot within which the jawbone is disposed.For example, as the jawbone is turned or revolved about its long axisthroughout the various angular orientation (0°, 90°, 180°, and 270°)shown in FIG. 8K, the corresponding boot can flex or assume variouscorresponding shapes as illustrated in FIGS. 8L-8O. Hence, as thejawbone rotates throughout the angular range, the shape of the boot andelectrode may flex and conform with the underlying configuration of thejawbone, whereas the angular orientation of the boot and electrode isunchanged.

For example, when the jawbone is in the 0° configuration shown in FIG.8K, the boot adopts the shape or configuration shown in FIG. 8L, wherethe tip or distal portion 810 l of the boot 800 l is disposed along thex-axis toward the A direction (e.g. 0° position), and the ablationmember or electrode 820 l faces toward the A direction. When the jawboneis in the 90° configuration shown in FIG. 8K, the boot adopts the shapeor configuration shown in FIG. 8M, where the tip or distal portion 810 mof the boot 800 m is disposed along the y-axis toward the B direction(e.g. 90° position), and the ablation member or electrode 820 m facestoward the A direction. When the jawbone is in the 180° configurationshown in FIG. 8K, the boot adopts the shape or configuration shown inFIG. 8N, where the tip or distal portion 810 n of the boot 800 n isdisposed along the x-axis toward the C direction (e.g. 180° position),and the ablation member or electrode 820 n faces toward the A direction.When the jawbone is in the 270° configuration shown in FIG. 8K, the bootadopts the shape or configuration shown in FIG. 8O, where the tip ordistal portion 810 o of the boot 800 o is disposed along the y-axistoward the D direction (e.g. 270° position), and the ablation member orelectrode 820 o faces toward the A direction. Thus, as the jawbone isrotatably adjusted throughout its range of motion, the correspondingline or zone of ablation that is created or defined by an ablationmember or electrode is rotated in a corresponding fashion.

Ball and Detent Embodiments

FIG. 9A depicts aspects of an adjustable clamp system 900 a according toembodiments of the present invention. As shown here, clamp system 900 aincludes a clamp assembly 910 a coupled with or in operative associationwith a base assembly 920 a. Clamp assembly 910 a has a first jawmechanism 912 a and a second jaw mechanism 914 a, and base assembly 920a has a first base mechanism 930 a and a second base mechanism 940 a.First jaw mechanism 912 a is coupled with first base mechanism 930 a,and second jaw mechanism 914 a is coupled with second base mechanism 940a. In use, first and second base mechanisms 930 a, 940 a are translatedrelative to one another, as indicated by arrow A, which in turn causesfirst jaw mechanism 912 a and second jaw mechanism 914 a to move towardor away from one another, as indicated by arrow B. According to someembodiments, first base mechanism 930 a may include a first base 932 acoupled with a first base shaft element 934 a. Relatedly, second basemechanism 940 a can include a second base 942 a coupled with a secondbase shaft element 944 a. As depicted here, second base shaft element944 a includes a channel or track 946 a that is configured to receive atongue 933 a of first base 932 a. Further, each of the first and secondjaw mechanisms may include a flexible boot coupled with a flexibleablation member, and optionally an end plug mechanism. For example,first jaw mechanism 912 a may include a flexible boot 911 a coupled witha flexible ablation member (not shown) and an end plug mechanism 916 a.Relatedly, second jaw mechanism 914 a may include a flexible boot 913 acoupled with a flexible ablation member 917 a and an end plug mechanism918 a. According to exemplary embodiments, each of the jaw mechanismsmay include a jawbone mechanism (not shown) disposed at least partiallywithin the flexible boot. Such jawbones may be configured to rotate orrevolve within or relative to the respective boots 911 a, 913 a, forexample. In some cases, the jawbones may rotate within the boots, whileflexible electrode mounting surfaces of the boots remaining facing oneanother, or toward the tissue which is being ablated by the treatmentsystem. As further discussed elsewhere herein, each of the jaws can befixed manually by depressing or actuating a ball detent mechanism.

FIG. 9B depicts aspects of an adjustable clamp system 900 b according toembodiments of the present invention. As shown here, clamp system 900 bincludes a clamp assembly 910 b coupled with or in operative associationwith a base assembly 920 b. Clamp assembly 910 b has a first jawmechanism 930 b and a second jaw mechanism 960 b, and base assembly 920b has a first base mechanism 950 b and a second base mechanism 980 b.First jaw mechanism 930 b can be coupled with first base mechanism 950 bvia a first rotational assembly 940 b and second jaw mechanism 960 b canbe coupled with second base mechanism 980 b via a second rotationalassembly 970 b. In some embodiments, one or more elements of firstrotational assembly 940 b are part of or integral to first basemechanism 950 b. In some embodiments, one or more elements of firstrotational assembly 940 b are part of or integral to first jaw mechanism930 b. In some embodiments, one or more elements of second rotationalassembly 970 b are part of or integral to second base mechanism 980 b.In some embodiments, one or more elements of second rotational assembly970 b are part of or integral to second jaw mechanism 960 b.

First jaw mechanism 930 b includes an internal jawbone 932 b that canrotate within a flexible boot 934 b. Similarly, second jaw mechanism 960b includes an internal jawbone 962 b that can rotate within a flexibleboot 964 b. The flexible boots 934 b, 964 b are coupled with basemechanisms 950 b, 980 b, respectively. Hence, each internal jawbone canrotate relative to its respective boot and base mechanism, while theboot and base mechanism remain rotationally stationary with regard toone another. However, the internal jawbones can be shaped so that theinterface configuration between the boots changes as the jawbonesrotate.

First rotational assembly 940 b allows internal jawbone 932 b toadjustably rotate relative to base mechanism 950 b and boot 934 b. Forexample, first rotational assembly 940 b may include a jawbone collar942 b within which jawbone 932 b may adjustably revolve, as indicated byarrow A. Similarly, second rotational assembly 970 b may include ajawbone collar 972 b within which jawbone 962 b may adjustably revolve,as indicated by arrow B. As shown here, first rotational assembly 940 bmay include a collapsible or compressible mechanism 944 b and secondrotational assembly 970 b may include a collapsible or compressiblemechanism 974 b. The compressible mechanism may include a spring, anelastomeric material, or any other suitable compressible device ormaterial.

FIG. 9C depicts aspects of an adjustable clamp system 900 c according toembodiments of the present invention. As shown here, clamp system 900 cincludes a clamp assembly 910 c coupled with or in operative associationwith a base assembly 920 c. Clamp assembly 910 c has a first jawmechanism 930 c, and base assembly 920 c has a first base mechanism 950c. First jaw mechanism 930 c can be adjustably coupled with first basemechanism 950 c, optionally via a first rotational assembly 940 c. Insome embodiments, one or more elements of first rotational assembly 940c are part of or integral to first base mechanism 950 c. In someembodiments, one or more elements of first rotational assembly 940 c arepart of or integral to first jaw mechanism 930 c. First jaw mechanism930 c includes an internal jawbone 932 c that can rotate within aflexible boot 934 c. The flexible boot can be coupled with or fixedrelative to base mechanism 950 c. Hence, internal jawbone 932 c canrotate relative to base mechanism 950 c, while the boot and basemechanism remain rotationally stationary with regard to one another.

First rotational assembly 940 c, or optionally base mechanism 950 c,allows internal jawbone 932 c to adjustably rotate relative to basemechanism 950 c and boot 934 c. For example, first rotational assembly940 c or base mechanism 950 c may include a jawbone collar 942 c withinwhich jawbone 932 c may adjustably revolve, as indicated by arrow A. Asshown here, first jawbone 932 c may include an internal channel 944 cthat houses a compressible mechanism 990 c. When the compressiblemechanism is sufficiently compressed, the jawbone is free to rotatewithin collar 942 c. When the compressible mechanism is sufficientlydecompressed or unsprung, the jawbone is prevented or inhibited fromrotating within collar 942 c. According to some embodiments,compressible mechanism 990 c includes a first contact 992 c having areceptacle 993 c, and a second contact 996 c having a shaft 997 c with areceptacle 998 c. Compressible mechanism 990 c also includes acompressible member 999 c disposed within receptacles 993 c and 998 c.The base mechanism or rotational assembly may include a stop 995 c forreceiving first contact 992 c and a stop 991 c for receiving secondcontact 996 c. A compressible member may include a spring, anelastomeric material, or any other suitable compressible element orcombination of elements. In some cases, a compressible member orassembly includes one or more rebounding members such as springs,elastomers, elasticized members, as described elsewhere herein. Thecompressible member 999 c can operate to urge or keep contacts 992 c,996 c engaged with the stops absent actuation by the user. For example,the contacts can be sprung outward radially, engaging the jaw base andpreventing or inhibiting jaw rotation.

In use, an operator may adjust the rotational position of internaljawbone 932 c by depressing or squeezing first and second contacts 992c, 996 c together or toward each other, thus compressing thecompressible member 999 c and moving the contacts 992 c, 996 c inwardfrom stops or pockets 991 c, 995 c, respectively. Once the contacts aresufficiently withdrawn from their stops or craters, the operator canrotate jawbone 932 c as indicated by arrow A. Base mechanism 950 c orrotational assembly 940 c may include a plurality of stops or pocketsinto which contacts 992 c, 996 c may fit. For example, the contacts maypresent hemispherical surfaces or projections that extend into thepockets, and than can be depressed by the operator back into the pocketsthus dislocating the jawbone for subsequent rotational movement. Hence,for example, when the operator has rotated jawbone 932 c to the desiredrotational configuration, the operator may release or reduce thesqueezing force applied to the contacts, thus allowing compressiblemember 999 c to decompress as contacts 992 c, 996 c move radiallyoutward into their respective stops when so aligned. If the contacts arenot aligned with the stops, the contacts remain in a compressedconfiguration, for example as they are constrained within jawbone collar942 c. In this sense, the jawbone and the compressible mechanism rotatein unison within or relative to the jawbone collar. When contacts 992 c,996 c are disposed within or otherwise engaged with the stops,compressible mechanism 990 c can operate to prevent or inhibitrotational movement of jawbone 932 c within collar 942 c.

Side Ratchet Embodiments

FIG. 10A depicts aspects of an adjustable clamp system 1000 a accordingto embodiments of the present invention. As shown here, clamp system1000 a includes a clamp assembly 1010 a coupled with or in operativeassociation with a base assembly 1020 a. Clamp assembly 1010 a has afirst jaw mechanism 1030 a, and base assembly 1020 a has a first basemechanism 1050 a. First jaw mechanism 1030 a can be adjustably coupledwith first base mechanism 1050 a, optionally via a first rotationalassembly 1040 a. In some embodiments, one or more elements of firstrotational assembly 1040 a are part of or integral to first basemechanism 1050 a. In some embodiments, one or more elements of firstrotational assembly 1040 a are part of or integral to first jawmechanism 1030 a. First jaw mechanism 1030 a includes an internaljawbone 1032 a that can rotate within a flexible boot 1034 a. Theflexible boot can be coupled with or fixed relative to base mechanism1050 a. Hence, internal jawbone 1032 a can rotate relative to basemechanism 1050 a as indicated by arrow A, while the boot and basemechanism remain rotationally stationary with regard to one another. Insome embodiments, the rotation may not be about the axis that is alongthe centerline of the end of the jawbone, where it is housed by the jawbase assembly. The end of the jawbone can travel in a circle around anaxis collinear with the proximal jawbone straight section. The clampsystem can include a moveable engagement mechanism 1060 a, optionally aspart of base assembly 1020 a or rotational assembly 1040 a. Engagementmechanism 1060 a includes first and second tangs or prongs 1062 a, 1064a. Relatedly, jawbone 1032 a includes recesses or apertures 1033 a, 1035a that are configured to receive or engage tangs 1062 a, 1064 a.Engagement mechanism 160 a can provide spring-actuated operation. Forexample, the engagement mechanism can operate to urge or forcespring-loaded engagement tangs into recesses or apertures of thejawbone.

FIG. 10B shows aspects of an adjustable clamp system 1000 b according toembodiments of the present invention. As shown here, clamp system 1000 bincludes a clamp assembly 1010 b coupled with or in operativeassociation with a base assembly 1020 b. Clamp assembly 1010 b has afirst jaw mechanism 1030 b, and base assembly 1020 b has a first basemechanism 1050 b. First jaw mechanism 1030 b can be adjustably coupledwith first base mechanism 1050 b, optionally via a first rotationalassembly 1040 b. In some embodiments, one or more elements of firstrotational assembly 1040 b are part of or integral to first basemechanism 1050 b. In some embodiments, one or more elements of firstrotational assembly 1040 b are part of or integral to first jawmechanism 1030 b. First jaw mechanism 1030 b includes an internaljawbone 1032 b that can rotate within a flexible boot 1034 b. Theflexible boot can be coupled with or fixed relative to base mechanism1050 b. Hence, internal jawbone 1032 b can rotate relative to basemechanism 1050 b as indicated by arrow A, while the boot and basemechanism remain rotationally stationary with regard to one another. Theclamp system can include a moveable engagement mechanism 1060 b,optionally as part of or coupled with base assembly 1020 b or rotationalassembly 1040 b. Engagement mechanism 1060 b includes first and secondtangs or prongs 1062 b, 1064 b. Relatedly, jawbone 1032 b includesrecesses or apertures 1033 b, 1035 b, 1037 b, 1039 b that are configuredto receive or engage tangs 1062 b, 1064 b.

Jawbone 1032 b also includes a groove or annular track 1038 b configuredto cooperatively associate with one or more bosses 1066 b, 1068 b ofengagement mechanism 1060 b. Bosses 1066 b and 1068 b are configured torotate or pivot relative to annular track 1038 b, as indicated by arrowsD and E, respectively. Bosses 1066 b, 1068 b may also operate to preventor inhibit axial translation of the jawbone along the long axis of thejawbone, for example when engaged with annular groove 1038 b. Theengagement mechanism can include a flexible ribbon of steel thatoperates as a spring. In use, an operator may squeeze or compresstogether a first portion 1061 b of engagement mechanism 1060 b, asindicted by arrows F and G, which causes bosses 1066 b, 1068 b to pivotor rotate relative to the annular track, as indicated by arrows D_(open)and E_(open), respectively. As a result, tangs 1062 b, 1064 b retractfrom recesses 1033 b, 1035 b, respectively, thus allowing jawbone 1032 bto freely rotate relative to base assembly 1020 b. In this way, bydeactivating or releasing the engagement mechanism, the operator cansubsequently rotate the jawbone to another desired orientation relativeto the base assembly. For example, in the configuration shown in FIG.10B, tangs 1062 b, 1064 b are engaged with recesses 1033 b, 1035 b,respectively. After releasing the engagement mechanism, the operator canrotate the jawbone by 180 degrees, and then reactivate or secure theengagement mechanism, so that tangs 1062 b, 1064 b are engaged withrecesses 1035 b, 1033 b, respectively. More specifically, the operatorcan let go or release compression at first portion 1061 b of engagementmechanism 1060 b, as indicted by arrows H and I, which causes bosses1066 b, 1068 b to pivot or rotate relative to the annular track, asindicated by arrows D_(close) and E_(close), respectively. As a result,tangs 1062 b, 1064 b protrude into recesses 1033 b, 1035 b,respectively, thus preventing or inhibiting jawbone 1032 b from freelyrotating relative to base assembly 1020 b. As shown here, engagementmechanism 1060 b includes a spring element 1063 b that biases or urgestangs or spring loaded tabs 1062 b, 1064 b toward the jawbone. In somecases, bosses 1066 b, 1068 b can rotate relative to hinge pins 1067 b,1069 b.

According to some embodiments, the presence of multiple recesses orapertures about the perimeter of the jawbone proximal end allow theengagement mechanism to lock the jawbone into a variety of usefulpositions. For example, where the jawbone provides a curved or othercontoured shape, the rotational orientation of the jawbone can beselected and locked as appropriate, so as to present a shape thatcontours or interfaces with the anatomical tissue as desired. In asystem that includes two jawbones, the first and second jawbones cantherefore be positioned so that the interface between the two jawbonesis disposed in a horizontal plane, a vertical plane, or any other planeas desired. In this way, the jawbone curves can provide opposingelectrode surfaces in any suitable plane for treating the patient. Asnoted elsewhere herein, a jawbone can include one or more recesses orholes which are configured to releasably receive tangs of an engagementmechanism. The jawbone can also includes a groove or annular trackconfigured to cooperatively associate with one or more engagementmechanism bosses. The jawbone groove can allow the boss, pin, or otherstationary feature relative to the base to locate the jawbone axially,prevent the jawbone from falling out of the base, and allow rotation ofthe jawbone relative to the base. Multiple holes or recesses can allowthe jawbone to be locked into useful positions so that jaw curves orelectrode faces of upper and lower jaw mechanisms oppose each other inhorizontal, vertical, or any other planes.

FIG. 10C shows aspects of an adjustable clamp system 1000 c according toembodiments of the present invention. As shown here, clamp system 1000 cincludes a clamp assembly 1010 c coupled with or in operativeassociation with a base assembly 1020 c. Clamp assembly 1010 c has afirst jaw mechanism 1030 c, and base assembly 1020 c has a first basemechanism 1050 c. First jaw mechanism 1030 c can be adjustably coupledwith first base mechanism 1050 c, optionally via a first rotationalassembly 1040 c. In some embodiments, one or more elements of firstrotational assembly 1040 c are part of or integral to first basemechanism 1050 c. In some embodiments, one or more elements of firstrotational assembly 1040 c are part of or integral to first jawmechanism 1030 c. First jaw mechanism 1030 c includes an internaljawbone 1032 c that can rotate within a flexible boot 1034 c. Theflexible boot can be coupled with or fixed relative to base mechanism1050 c. Hence, internal jawbone 1032 c can rotate relative to basemechanism 1050 c as indicated by arrow A, while the boot and basemechanism remain rotationally stationary with regard to one another. Theclamp system can include a moveable engagement mechanism 1060 c,optionally as part of or coupled with base assembly 1020 c or rotationalassembly 1040 c. Engagement mechanism 1060 c includes one or more tangs1062 c, and jawbone 1032 c includes one or more recesses (not shown)that are configured to receive or engage an engagement tang. In use, anoperator may squeeze the engagement mechanism as indicated by arrow B,for example at activation area 1070 c, which is located proximal topivot boss 1066 c. As a result of such actuation, a proximal springportion 1061 c bows outward or backward as indicated by arrow C, andtang 1062 c is released from engagement with the jawbone, thus allowingthe jawbone to rotate. According to some embodiments, proximal springportion 1061 c can provide a snag-free spring.

Tuning Fork Embodiments

FIG. 11A illustrates aspects of a proximal portion of a jawbone 1132 aaccording to embodiments of the present invention. Jawbone 1132 aincludes one or more protrusions or buttons 1133 a, 1137 a which areconfigured to releasably engage one or more recesses of an engagementmechanism or base assembly. Jawbone 1132 a also includes a groove orannular track 1138 a configured to cooperatively associate with one ormore engagement mechanism or base assembly bosses. The axial securinggroove can keep the jawbone from moving lengthwise, or otherwise locatethe jawbone relative to the base, while at the same time allowing thejawbone to rotate relative to a base or boot. A pin or boss in the base,for example a pin or boss similar to that which is described inassociation with pins 1067 b, 1069 b or bosses 1066 b, 1068 b shown inFIG. 10B, can be positioned to intersect the groove. Optionally, thejawbone can be used in conjunction with an anchoring mechanism fixedrelative to a base, such that the anchoring mechanism provides anchorelements that can be positioned or disposed tangentially through orradially into the side of the groove, thus allowing the jawbone torotate while maintaining the jawbone in an axially stationary position.In this sense, a pin or boss can help to locate the jawbone, and keep itsecured at an axial location relative to the base. As shown here, theprotrusions or tangs 1133 a, 1137 a are disposed toward the ends ofrespective flexible fingers 1135 a, 1139 a of the jawbone. With regardto flexible finger 1135 a, the finger can be formed by a “U” shaped cut1136 a in a side wall 1134 a of the jawbone. Accordingly, the base ofthe fingers may be continuous with the body of the jawbone. Flexiblefinger 1135 a may also include one or more flexibility slits or thinsections 1131 a that allow the flexible finger to more easily flex ormove with respect to the jawbone, for example when the operator or usersqueezes against buttons or pins 1133 a, 1137 a, as indicated by arrowsA and B, respectively. Hence, by squeezing the buttons, the operator canforce the buttons toward the central longitudinal axis of the jawbone.The protrusions can act as rotationally locking mechanisms. Theprotrusions can also act as manual push buttons that can engagecorresponding holes or apertures in a base or rotational assembly.Jawbone 1132 c can be used in conjunction with other aspects of atreatment system, such as those shown in FIG. 9C. For example, jawbone1132 c can be placed in operative association with a collar similar tocollar 942 c of treatment system 900 c. Likewise, buttons 1133 a, 1137 acan be compressed or relaxed so as to engage or disengage from thepockets or craters shown in FIG. 9C.

FIG. 12A depicts aspects of an ablation member or electrode assembly1200 a according to embodiments of the present invention. As shown here,ablation member assembly 1200 a can include an ablation member 1210 asuch as an electrode, optionally in combination with a flexible supportor boot 1220 a. In some cases, boot 1220 a includes a polymer sleeve,which may include urethane or another flexible material. The electrodeassembly is flexible in three dimensions, and thus can accommodaterotational movement of a curved jawbone disposed within the interior ofthe boot. For example, the electrode assembly may flex relative to thex-axis, the y-axis, and the z-axis of a standard Cartesian coordinatesystem. The ablation member can be anchored or embedded into theflexible boot. Relatedly, FIG. 12B shows aspects of an ablation member1210 b according to embodiments of the present invention. In some cases,ablation member 1210 b can include a flexible electrode. The electrodeillustrated here provides a generally serpentine shape. In some cases,an electrode can present an accordionated or other repetitively shapedconfiguration. As shown here, ablation member 1210 b includes aplurality of alternating looped or curved sections. In some cases, theablation member assembly may provide one or more sections that moredensely arranged loops, such that loops are present at a higher pitch orcount per length. In some cases, the ablation member assembly mayprovide one or more sections that more loosely arranged loops, such thatloops are present at a lower pitch or count per length. Ablation member1210 b can flex sideways, up and down, and in an S-curve configuration.As depicted here, ablation member 1210 b can be a thin flexible elementthat bends without yielding. In some cases, an ablation member caninclude one or more break points 1212 b that present structurallyweakened sections. As shown here, the break points are configured in ahourglass shape. An operator may sharply bend the electrode at the breakpoints, causing the electrode to break at the break point, so as tocreate multiple smaller electrode pieces. Optionally, sharp edges ofbroken break points can be ground away or otherwise smoothed prior tofurther use. As noted elsewhere herein, ablation member 1210 b caninclude one or more tangs or barbed points 1214 b According to someembodiments, tangs or anchoring pints 1214 b can operate to help providea mechanical connection between an ablation member 1210 b and a flexibleboot. In some cases, an adhesive can also be used to help provide achemical connection or bond between an ablation member an a flexibleboot. When the ablation member and boot are suitably secured with oneanother, a flexing motion of the boot creates a corresponding flexingmotion in the ablation member. When operating as an indifferentelectrode, ablation member 1210 b may be coupled with a single wire.When operating as an active electrode, ablation member 1210 b may becoupled with an RF wire, for example at a central portion of theablation member, and two thermocouple pairs, for example at opposing endportions of the ablation member. In some cases, the ablation member canhave a width W within a range from about 0.050 to about 0.150 inches.

Because a boot and an electrode can flex in unison, the ablationassembly can accommodate any of a variety of surgical situations, suchas when the patient tissue presents surface irregularities, changes insurface density, changes in tissue density, changes in tissue thickness,and the like. Thus, two opposing jaw mechanisms can provide equilibratedor normalized pressure to both sides of the tissue, even where thetissue presents lumps or bumps between the jaw members. The boots andelectrodes can bend, pivot, rotate, twist, or otherwise conform toaccommodate the tissue that is being clamped. In some cases the boot andelectrode assembly bends along the length of the assembly. In somecases, the boot and electrode assembly bends from side to side. Hence,the ablation assembly can maintain a maximal amount of contact with thesurface of the tissue, while the electrode twists and conforms with thetissue surface irregularities. Relatedly, the ablation assembly providesa maximal amount of contact while minimizing high or extreme pressurepoints. For example, where the contact pressure would otherwise behigher, the electrode assembly can accommodate the tissue and thereforetransmit a relatively lower amount or percentage of clamping force tothat tissue point. Conversely, where the contact pressure wouldotherwise be lower, the electrode assembly can accommodate the tissueand therefore transmit a relatively higher amount or percentage ofclamping force to that tissue point. Accordingly, the treatment systemcan provide improved surface contact and equalized pressure along thelength of and across the sides of the ablation members or electrodes. Insome cases the compliant nature of the jaw surface and electrode allowsthese elements to conform to tissue irregularities. In some cases, anelectrode can have a length of about 70 mm.

FIG. 13 depicts aspects of an ablation member or electrode assembly 1300according to embodiments of the present invention. As shown here,ablation member assembly 1300 can include an ablation member 1310 suchas an electrode, optionally in combination with a flexible support orboot 1320. The electrode illustrated here provides a generally fishboneshape, and includes a central rib 1312 and one or more laterallyextending side ribs 1314. According to some embodiments, ablation member1310 and boot 1320 are both pliant, and can flex in a coordinatedmanner. The ablation member assembly 1300 can flex as a unitaryensemble, such that the ablation member and boot move in a coordinatedmanner in three dimensions with respect to the x-axis, y-axis, andz-axis of a Cartesian coordinate system. In an exemplary embodiment, atreatment system includes two electrode assemblies, each of which isflexible in three dimensions, whereby the position of the respectiveelectrodes is maintained such that an electrode of one assembly facestoward a corresponding electrode of the other assembly. Electrodes caninclude a thin metal material, and can bend without yielding. In somecases, an electrode can present a serpentine or accordionated shape. Insome cases, an electrode can have a series of aligned elements situatedalong a central element or axis.

Flat Plate Electrode Embodiments

FIG. 14A depicts aspects of an adjustable clamp system 1400 a accordingto embodiments of the present invention. As shown here, clamp system1400 a includes a clamp assembly 1410 a coupled with or in operativeassociation with a base assembly 1420 a. Clamp assembly 1410 a has afirst jaw mechanism 1412 a and a second jaw mechanism 1414 a, and baseassembly 1420 a has a first base mechanism 1430 a and a second basemechanism 1440 a. First jaw mechanism 1412 a is coupled with first basemechanism 1430 a, and second jaw mechanism 1414 a is coupled with secondbase mechanism 1440 a. In use, first and second base mechanisms 1430 a,1440 a are translated relative to one another, as indicated by arrow A,which in turn causes first jaw mechanism 1412 a and second jaw mechanism1414 a to move toward or away from one another, as indicated by arrow B.According to some embodiments, first base mechanism 1430 a may include afirst base 1432 a coupled with a first base shaft element 1434 a.Relatedly, second base mechanism 1440 a can include a second base 1442 acoupled with a second base shaft element 1444 a. As depicted here,second base shaft element 1444 a includes a channel or track 1446 a thatis configured to receive a tongue 1433 a of first base 1432 a. The jawmechanisms 1412, 1414 a may also include one or more ablation members orelectrodes. For example, first jaw mechanism 1412 a may include one ormore ablation members 1417 a and second jaw mechanism 1414 a may includeone or more ablation members 1416 a, 1418 a. Ablation members can beactive or indifferent. Typically, an ablation member of one jawmechanism faces toward an ablation member of the other jaw mechanism. Insome cases, a jaw mechanism may include a base member in operativeassociation with an electrode. For example, as shown here, jaw mechanism1414 a includes a base member 1415 a coupled with ablation members 1416a, 1418 a and a jaw mechanism support 1419 a. First jaw mechanism 1412 amay include a similar arrangement. In some cases, jaw mechanism support1419 a includes a metallic material such as steel, and base member 1415a includes a non-metallic material such as plastic. Base member may insome instances include a material that provides electrical insulation,thermal insulation, or both. Optionally, base member 1415 a can includea flexible or deformable material, such as an elastomer. Hence, theelectrodes can be isolated, either electrically, thermally, or both,from the base jaws which may be constructed of metal such as steel.Electrical isolation of the electrodes can prevent them from beingground. In some cases, a jaw mechanism may include any number ofablation members. For example, a jaw mechanism may include 10 or moreablation members. Accordingly, the jaw mechanism can present a flexibleor conformable configuration, wherein multiple ablation members aredisposed upon a flexible or deformable base member. In some cases, aseries of multiple nonflexible ablation members may operate on the wholeor collectively as a single flexible ribbon. The ablation members mayinclude elements of a cooling apparatus. In use, the ablation memberscan absorb heat from tissue which is being ablated. Saline or othercooling fluid may be routed along the ablation members, or otherelements of the jaw mechanism, so as to draw heat away from the ablationmembers. In some cases, ablation members may have connection points forcoupling with other system features. For example, ablation member 1418 acan have a connection point 1472 a for coupling with an RF element, aconnection point 1474 a for coupling with a distal thermocouple pair,and a connection point 1476 a for coupling with a proximal thermocouplepair. In some cases, ablation member 1417 a can be configured as anindifferent electrode.

FIG. 14B illustrates an ablation member 1400 b according to embodimentsof the present invention. In some cases, ablation member 1400 b includesa non-compliant or rigid material such as steel. In some cases, anablation member can include a flexible material, or can otherwise beconfigured to present a flexible configuration. FIG. 14C shows an endview or cross-section of an exemplary clamp assembly 1400 c. As shownhere, the clamp assembly includes a first jaw mechanism 1410 c and asecond jaw mechanism 1420 c. First jaw mechanism 1410 c includes ajawbone 1412 c disposed toward the interior of a boot 1414 c, and anelectrode 1416 c disposed toward the exterior of boot 1414 c. Second jawmechanism 1420 c includes a jawbone 1422 c disposed toward the interiorof a boot 1424 c, and an electrode 1426 c disposed toward the exteriorof boot 1424 c. The clamp assembly can provide compliance during atreatment, so as to accommodate tissue having various thicknesses,densities, irregularities, and the like. For example, as shown in FIG.14D, the flexible boot and electrode can flex and conform with a patienttissue. Clamp assembly 1400 d includes a first jaw mechanism 1410 d anda second jaw mechanism 1420 d that can engage a patient tissue T. Firstjaw mechanism 1410 d includes a jawbone 1412 d disposed toward theinterior of a boot 1414 d, and an electrode 1416 d disposed toward theexterior of boot 1414 d. Second jaw mechanism 1420 d includes a jawbone1422 d disposed toward the interior of a boot 1424 d, and an electrode1426 d disposed toward the exterior of boot 1424 d. As shown here,flexible boots 1414 d, 1424 d and flexible electrodes 1416 d, 1426 d canbend or flex so as to conform with or accommodate the shape of tissue T,optionally while jawbones 1412 d, 1422 d do not bend or flex relative toone another. Such flexible clamp assemblies can be used to clamp tissue,while providing equalized or balanced clamping forces toward each clampsite on the tissue. A high degree of tissue contact can be maintained,without producing unwanted high or extreme pressure points on thetissue.

Cooling Apparatus Embodiments

In some cases, the thermal mass of the jaw construction can allow thedevice to operate effectively without a cooling mechanism for theelectrodes. In some cases, a device includes thick urethane boots overthe steel jawbone which insulates the electrode from the heat sinkeffect of the jawbone. In the cooled design herein described, thejawbone in one example is an active part of the cooling system.

During the operation of an ablation system, applied RF energy can causean increase in tissue temperature, which in turn causes an increase intemperature in the ablation system elements. If certain elements of thetreatment system, such as the electrodes, become excessively hot, theymay char or damage the surface of the tissue with which they are incontact. In a treatment system having rigid jaws, a cooling apparatusmay include tubes or passages extending along the length of the deviceshaft. A fluid delivery tube can deliver cooling fluid through a clampjaw, and across or near heated elements of the jaw so as to absorb heatfrom those elements. A fluid return tube can carry the heated fluid awayfrom the clamp jaw. In this way, a cooling apparatus can operate as aheat sink, removing unwanted heat from electrodes or other elements of atreatment system. FIG. 15 shows aspects of a cooling system 1500according to embodiments of the present invention. Cooling system 1500includes two concentrically arranged tubes or passages. A smaller,narrower fluid delivery tube 1510 is disposed within a larger, widerfluid return tube 1520. As shown here, fluid delivery tube 1510 operatesto deliver cooling fluid, such as saline, through a treatment systemshaft 1530 in a distal direction as indicated by arrow A, and into aninterior passage 1542 of a hollow jawbone 1540 as indicated by arrow B.Typically, fluid is delivered through delivery tube 1510 at a relativelyhigh pressure. The cooling fluid passes distally through jawbone 1540,and exits a distal section of the jawbone at fluid port 1544. In somecases, the smaller tube carry the inflow water to a location close tothe plugged distal end of the jawbone where the water exits the smalltube and flows back inside the jawbone, thereby carrying away heatpicked up by the jawbone. Optionally, tube 1520 can be connecteddistally to the jawbone to pick up the water, and not outside thejawbone as depicted in FIG. 15. The fluid then flows in a proximaldirection as indicated by arrow C, across or near an electrode 1550 thatis coupled with a boot 1560, and across or near the outside or exteriorof the jawbone. In this way, the fluid can absorb heat from theelectrode, the boot, or the jawbone, or any combination thereof. Thefluid then continues to flow proximally into the shaft as indicated byarrow D, and through fluid return tube 1520 toward a fluid source orreturn depot, as indicated by arrow E. In some cases, a treatment systemhandle may include a manifold that is configured to fluidly couple withfluid delivery tube 1510 and fluid return tube 1520. In someembodiments, boot 1560 may include thermally transmissive materials ormetallic-loaded plastics, such as carbon, graphite, or other additives,which operate to transmit thermal energy from the boot or electrodetoward the jawbone. Although the jawbone may not directly contact theelectrode, thermal energy can be transmitted from the electrode, throughthe boot, and to the jawbone. According to some embodiments, the bootcan have a thickness of a few thousandths of an inch. In some cases, thethickness of the boot can be within a range of about 0.01 inch to about0.1 inch.

In some embodiments, the end plugs can have either a cross hole or endhole through them or it, for example on the bottom jaw, for a suture orsurgical tape to pass through providing a tension member forintroduction that would help slip the bottom jaw into place withoutsnagging tissue or vessels. The lower jaw can be the one not seen duringinsertion and it can be of help to surgeons if they knew that it wouldbe guided into place automatically. For example, the tension member canbe made slippery/atraumatic by sliding a rubber or polymer tube over itand clamping the distal end. An introducer system can be adapted for usewith the clamp, including the use of a magnetic tipped introducer.Additionally the introducer tube or tape can be fitted with a distalpocket so that it can be placed with a straight or malleable or curvedor curvable tipped instrument, which can also be used as a tissuedissector. In some embodiments, the clamp can include or be used with anintroducer that is attached without means of detachment other thancutting it off with scissors or knife. If it is chosen to be cut, thetension member can stop functioning and the pieces can be removed anddiscarded at any time before, during, or after surgery.

Frame Button Embodiments

Embodiments further encompass systems wherein the operator can push oractivate a button or switch that rotates the jawbones. For example, asystem can be configured so that the jaws will rotate 90° in onedirection per push or “click” of the button. The surgeon can click thebutton in the jaw base until the jawbone is aligned as he or shedesires. Hence, these embodiments provide a one-handed, intuitiveoperation to position the jawbone. Frame button configurations asdescribed in relation to FIGS. 16A-16S provide an illustrative exampleof such embodiments. It is understood that although FIGS. 16A-16S do notshow complete details of an entire adjustable clamp system, theembodiments depicted in FIGS. 16A-16S may include structural aspects orelements of other adjustable clamp system embodiments disclosed herein.

FIG. 16A depicts aspects of an adjustable clamp system 1600 according toembodiments of the present invention. Clamp system 1600 includes a clampassembly 1610 coupled with or in operative association with a baseassembly 1620. Clamp assembly 1610 has a first jaw mechanism 1612 and asecond jaw mechanism (not shown), and base assembly 1620 has a firstbase mechanism 1630 and a second base mechanism (not shown). Clampingprocedures involving relative translation between the base mechanismsand jaw mechanisms are similar to those described herein with referenceto FIG. 9A, for example, and are not described in detail here to avoidprolixity. Further, each of the first and second jaw mechanisms mayinclude a flexible boot coupled with a flexible ablation member, andoptionally an end plug mechanism. For example, first jaw mechanism 1612may include a flexible boot 1611 coupled with a flexible ablation member1613 and an end plug mechanism (not shown). Boot 1611 may include orpresent an electrode mounting surface 1611 a. According to exemplaryembodiments, each of the jaw mechanisms may include a jawbone mechanismdisposed at least partially within the flexible boot. For example, jawmechanism 1612 may include a jawbone mechanism 1614 disposed at leastpartially within boot 1611. Such jawbone mechanisms may be configured torotate or revolve within or relative to the respective boots, forexample. Further, such jawbone mechanisms may be configured to rotate orrevolve within or relative to the respective base mechanisms, forexample. In some cases, the jawbones or jawbone mechanisms may rotatewithin the boots, while flexible electrode mounting surfaces of theboots remaining facing one another, or toward the tissue which is beingablated by the treatment system. As further discussed elsewhere herein,jawbone mechanisms can be alternately rotated or fixed manually bydepressing or actuating a frame button mechanism 1700.

FIG. 16B depicts aspects of an adjustable clamp system 1600 according toembodiments of the present invention. FIG. 16B provides a moretransparent view of aspects of system 1600, and does not show theflexible boot, as compared with FIG. 16A. Clamp system 1600 includes aclamp assembly 1610 coupled with or in operative association with a baseassembly 1620. Clamp assembly 1610 has a first jaw mechanism 1612 and asecond jaw mechanism (not shown), and base assembly 1620 has a firstbase mechanism 1630 and a second base mechanism (not shown). Each of thefirst and second jaw mechanisms may include a flexible boot coupled witha flexible ablation member, and optionally an end plug mechanism. Forexample, first jaw mechanism 1612 may include a flexible boot (notshown) coupled with a flexible ablation member 1613 and an end plugmechanism (not shown). Jaw mechanism 1612 may include a jawbonemechanism 1614 configured to rotate or revolve within or relative to theboot, for example. Further, such jawbone mechanisms may be configured torotate or revolve within or relative to the respective base mechanisms,for example. In some cases, the jawbones or jawbone mechanisms mayrotate within the boots, while flexible electrode mounting surfaces ofthe boots remaining facing one another, or toward the tissue which isbeing ablated by the treatment system. As further discussed elsewhereherein, jawbone mechanisms can be alternately rotated or fixed manuallyby depressing or actuating a frame button mechanism 1700.

Jaw mechanism 1612 can be adjustably coupled with base mechanism 1630,optionally via a rotational assembly 1640. In some embodiments, one ormore elements of rotational assembly 1640 are part of or integral tobase mechanism 1630. In some embodiments, one or more elements ofrotational assembly 1640 are part of or integral to jaw mechanism 1612.Jaw mechanism 1612 includes an internal jawbone 1614 that can rotatewithin a flexible boot. The flexible boot can be coupled with basemechanism 1630. Hence, internal jawbone 1614 can rotate relative to basemechanism 1630, while the boot and base mechanism 1630 remainrotationally stationary with regard to one another. As shown here,rotational assembly 1640, base mechanism 1630, or jaw mechanism 1612 mayinclude a jawbone collar 1642. Jawbone 1614 may adjustably revolverelative to base mechanism 1630 and boot 1611, as indicated by arrow A.For instance, an operator may rotate the jawbone without rotating theboot or electrode, by actuating frame button 1700. As further discussedelsewhere herein, a single actuation or push-and-release of button 1700can cause jawbone 1614 to rotate 90 degrees. Two actuations orpush-and-release cycles of button 1700 can cause jawbone to rotate 180degrees, for example from a left curve configuration to a right curveconfiguration, or from a right curve configuration to a left curveconfiguration.

First jaw mechanism 1612 and first base mechanism 1630 can move in theupward and downward directions, relative to an elongate shaft (notshown) to which the base mechanism is slidably coupled, as indicated byarrow B. Although many of the features depicted in FIGS. 16A-16S may bediscussed in terms of a first or upper clamp assembly 1610, it isunderstood that such features can also be incorporated into a second orlower clamp assembly of clamp system 1600. As viewed through thetransparently illustrated base mechanism 1630, it can be seen thatbutton 1700, which extends through jaw base mechanism 1630, includes avertical engagement pad 1710, an upper horizontal arm 1720, a lowerhorizontal arm 1730, and a vertical arm 1740. Jawbone mechanism 1614 mayinclude a jawbone base 1616 that can rotate within an inner bearingsurface of jawbone collar 1642. As shown here, jawbone base 1616 isencircled by frame button 1700, and includes a set of gear teeth orindentations 1616 a that are adapted to receive teeth of the framebutton. Jawbone base 1616 also includes a first aperture 1616 b, and asecond aperture 1616 c that intersects first aperture 1616 b. Theseapertures can operate to engage with a leaf spring, as describedelsewhere herein.

FIG. 16C shows an opposing side of first base mechanism 1630. Boot 1611is depicted transparently, so that jawbone 1614 can be seen. Baseassembly 1620 includes a leaf spring mechanism 1622 attached with jawbase 1630 via an attachment point 1621. The outer surfaces of the leafspring mechanism and the nearby jaw base are flush, thus providing anarrow or thin profile. Leaf spring mechanism 1622 is shown here in aninward configuration, such that it fits within a horizontal groove 1631of base mechanism 1630 and contacts vertical arm 1740 of the framebutton. Accordingly, upward and downward movement of spring mechanism1622 as indicated by arrow A is inhibited or prevented. In use, when theoperator presses on the vertical engagement pad of the frame button, thevertical arm of the button extends through vertical groove 1633 of base1630, and presses against leaf spring 1622. In this way, the buttonactuation causes the proximal outer surface of the leaf spring toprotrude out of base mechanism groove 1631, while the distal section ofthe spring remains tight against base mechanism 1630 due to theconnection at attachment point 1621. It is helpful for the operator tonot press or hold leaf spring against base mechanism 1630 when actuatingthe button engagement pad, so as to allow leaf spring to flex away fromapertures 1616 b and 1616 c, as described elsewhere herein. Hence, theoperator's opposing finger can be placed on the base mechanism 1630 orboot 1611 during the button actuation.

FIG. 16D shows an alternative construction for the jaw base, as comparedwith FIG. 16C. As depicted in FIG. 16D, jaw base 1630′ includes aprotrusion or prominence 1634′. Hence, the proximal outer surface of thespring mechanism is set back from the outer surface of the nearby jawbase. Accordingly, during use, the operator may place the opposingfinger on prominence 1634′ when pressing against the engagement pad ofthe frame button. The deeper grooves 1631′ and 1633′ allow the verticalarm of the frame button, as well as the proximal section of the leafspring 1622′, to extend outward radially when the button is pushed,while the operator's actuating finger and opposing finger are locateddirectly opposite one another on the jaw base 1630′. Hence, the leafspring is buried in the bulging counter-button shape or prominence sothat the leaf spring remains within the solid base envelope when flexed.The opposing finger can be placed on the counter-button shape todirectly oppose the force applied by the actuating finger. The raisedprotuberance 1634′ resembles a circular bump on the side of jaw base1630′ opposite the frame button engagement pad. This configurationallows the operator to apply a squeezing force on both sides of the jawbase with opposing fingers, pressing in against both sides. The presenceof deeper grooves 1631′ and 1633′ prevent the operator's finger fromlimiting movement or flexion of leaf spring 1622′ during the squeezingmotion, thus accommodating a full range of motion for the frame buttonwhen pressed. Hence, the raised boss 1634′ facilitates unrestrictedflexing of the leaf spring and movement of the frame button.

FIG. 16E shows aspects of the interaction between frame button 1700,leaf spring mechanism 1622, and jawbone base 1616 according toembodiments of the present invention. Leaf spring 1622 has a proximalsection that includes a curved or hooked end 1622 a that can engageapertures 1616 b, 1616 c of jawbone base 1616. When the leaf spring ison the relaxed or unflexed configuration, such as when it is not beingpushed outward by the frame button, the tab 1622 a is engaged with thejawbone base apertures, thus preventing or inhibiting the jawbone basefrom rotating about a longitudinal jawbone base axis 1616′ as indicatedby arrow A. In some instance, the proximal section of leaf spring 1622is biased to press radially inward toward apertures 1616 b, 1616 c.Optionally, the leaf spring mechanism can be configured as a straightbar with no bias. Leaf spring mechanism 1622 can operate to constrainthe rotation of jawbone base 1616. As noted elsewhere herein, leafspring 1622 can be situated within a groove of the jaw base (not shown)when the leaf spring is in the unflexed configuration, thus preventingupward and downward movement of the leaf spring, which furtherconstrains rotational movement of the jawbone base. Leaf springmechanism 1622 includes a distal portion that is attached with the jawbase (not shown) at an anchor point 1621. This attachment point mayinclude a spot weld, a screw, a pin, or the like. During use, theoperator presses against engagement pad 1710 of button 1700, thus movingbutton 1700 in the direction indicated by arrow B. Accordingly, verticalarm 1740 of the frame button presses against the leaf spring mechanism,thus moving tab 1622 a out of aperture 1616 c in the direction indicatedby arrow C, as the leaf spring pivots about attachment point 1621. Theleaf spring may present some amount of resistance to this buttonmovement, as the spring bends or flexes in this hinged manner. However,the force applied by the user's finger overcomes the leaf springresistance. In this way, actuation of button 1700 can allow jawbone base1616 to rotate in the direction indicated by arrow A. As furtherdescribed elsewhere herein, in addition to allowing jawbone baserotation, actuation of button 1700 also forces rotation of the jawbonebase due to engagement between teeth or pawl of the frame button andteeth or indentations of the jawbone base. When the finger pressure isreleased, the leaf spring returns toward an unflexed configuration, thusmoving the button in the direction indicated by arrow D. It is alsonoted that the horizontal arms of the button may flex slightly duringactuation. For example, when force is applied against engagement pad inthe direction indicated by arrow E, a central portion of upperhorizontal arm 1720 may flex upwardly in the direction indicated byarrow F. Similarly, when force is applied against engagement pad in thedirection indicated by arrow E, a central portion of lower horizontalarm 1730 may flex downwardly in the direction indicated by arrow G. Asfurther described elsewhere herein, such flex is directly caused by theback side of frame button engagement tooth, which is shaped like a ramp,as the tooth is forced backward over a jawbone base tooth. The flexallows the frame button tooth to ratchet into a new engagement position,for example from a position between jawbone base teeth 1616 a(8) and1616 a(1) as shown in FIG. 16L, to a position between teeth 1616 a(1)and 1616 a(2) as shown in FIG. 16O, and to a position between teeth 1616a(2) and 1616 a(3) as shown in FIG. 16P. Hence, the force applied to thebutton pad by the operator acts as an indirect cause, and the rampingforce conferred by the jawbone base tooth acts as a direct cause, forthe flexing of the horizontal button frame arm. Jawbone base 1616includes grooves or indents 1616 a that are adapted to engage teeth ofthe frame button. In some embodiments, jawbone base 1616 is constructedof a single piece of metal or other suitable material. In someinstances, jawbone base 1616 may be machined or metal injection molded.

FIG. 16F shows aspects of jawbone base 1616 according to embodiments ofthe present invention. Jawbone base 1616 includes or defines an innerlumen or cylindrical passage 1617, which operates as a socket thatreceives a proximal section of a jawbone (not shown). Jawbone base 1616also includes or defines distal and proximal outer rotary bearingsurfaces 1618 a, 1618 b, that engage or are received within acorresponding inner bearing surface of a jaw base (not shown). Asdepicted here, jawbone base 1616 includes one or more jawbone baseratchet teeth 1616 a, which may be formed by cutting or creating one ormore indents or recesses 1616 d in the body of the jawbone base. Thesegrooves 1616 d, which may be integral to and disposed annularly aboutthe jawbone base, can be configured to engage teeth or pawls of a framebutton (not shown). Jawbone base 1616 also includes leaf spring toothengagement holes 1616 b, 1616 c, which may be located circumferentiallyabout the jawbone base, for example so as to provide engagementlocations at 90 degree intervals. Engagement holes can be constructed bydrilling or forming two or more intersecting cylinders or bores throughthe body of the jawbone base.

FIG. 16G illustrates aspects of a frame button 1700 according toembodiments of the present invention. As shown here, button 1700includes an engagement pad 1710, an upper arm 1720 having an upper armtooth 1721, a lower arm 1730 having a lower arm tooth 1731, and avertical arm 1740 having a vertical arm tooth 1741. Upper and lower arms1720, 1730 are configured to flex or bend during actuation of the framebutton. The engagement pad can be circular in shape, and approximatelythe diameter of a ballpoint pen cap. As shown here, upper and lowerteeth 1721, 1731 have opposing engagement faces 1722, 1732,respectively, which operate as drivers for urging the jawbone base (notshown) in a rotary manner. Vertical arm tooth 1741 may be shapedslightly different from the upper and lower teeth, and may operate as astop for the jawbone base during actuation of the frame button. Forexample, as described elsewhere herein, when reaching the end of a throwmovement or button stroke actuation, vertical tooth 1741 can engage ajawbone base tooth, thus stopping motion of the jawbone base in aprecise orientation so that the leaf spring can engage with a leafspring engagement hole of the jawbone base. As shown here, upper tooth1721 includes an engagement face 1722 and an engagement ramp 1723. Lowertooth 1731 includes an engagement face 1732 and an engagement ramp 1733.Vertical tooth 1741 includes an upper engagement face 1742, that isangled, and a lower engagement ramp 1743. In use, ramps such as uppertooth engagement ramp 1723 and lower tooth engagement ramp 1733 canoperate to slide over a jawbone base tooth when moving in a non-engageddirection.

Upper engagement face 1742 provides an angled face that operates to actas an engagement point, for example as shown in FIGS. 16L, 16M, and 16S,with a jawbone base tooth. With reference to FIG. 16O, upper engagementface 1742 can provide an angled surface that engages a jawbone basetooth at a contact location disposed above a horizontal line 1601 thatextends from a jawbone center of rotation 1614″ to tooth 1741. Tomaintain parallel engagement with the jawbone base tooth, upperengagement face 1742 can be angled such that an extension of a plane1602 of its face can cross through or intersect the center of rotationof the jawbone base 1614″. In this way, upper engagement face 1742 maybe radially lined up with jawbone base center 1614″.

FIG. 16H illustrates aspects of a jaw base 1630 according to embodimentsof the present invention. FIG. 16I shows a side view of jaw base 1630opposing that of the view depicted in FIG. 16H. FIG. 16J shows across-section view of jaw base 1630 sectioned lengthwise. Jaw base 1630includes a bore or inner bearing surface 1643 that can engage outerrotary bearing surfaces of a jawbone base (not shown). A good fitbetween the inner jaw base bore and the outer jawbone base bearingsurface allows the jawbone base to rotate within the jaw base withminimal or no axial or translational wiggle or slop. FIG. 16K shows across-section view of jaw base 1630 sectioned crosswise. Each of FIGS.16H to 16K illustrate cutouts or apertures in the jaw base which receivevarious systems components, such as the frame button, the leaf springtab, and the like. For example, jaw base 1630 includes an upper track1630 a that slidingly receives an upper horizontal arm of a framebutton, and a lower track 1630 b that slidingly receives a lowerhorizontal arm of a frame button. As shown in FIG. 16J, jaw base 1630may include a wire passage or track 1635 that receives a wire fordelivering energy to an ablation electrode. In some cases, wires extendthrough a shaft in the treatment device, for delivering energy orelectrical signals between an ESU and various jaw components such as ajaw electrode. Jaw base 1630 is well suited for fabrication by metalinjection molding (MIM).

FIGS. 16L to 16S illustrate how a single push-and-release actuation ofthe frame button can rotate the jawbone by 90 degrees. That is, a pushmotion to move the button from an outward position to an inward positionoperates to rotate the jawbone by 45 degrees, and a release motion toallow the button to move from the inward position to the outwardposition operates to rotate the jawbone by an additional 45 degrees,thus resulting in a sum rotation of 90 degrees. Two push-and-releaseactuations can therefore rotate the jawbone by 180 degrees.

As depicted in FIG. 16L, prior to actuation, engagement face 1722 ofupper button arm 1720 is disposed near tooth 1616 a(5) of the jawbonebase, between teeth 1616 a(5) and 1616 a(6), engagement face 1732 oflower button arm 1730 is disposed near tooth 1616 a(8), between teeth1616 a(8) and 1616 a(1), and upper engagement face 1742 of vertical arm1740 is disposed near tooth 1616 a(3), between teeth 1616 a(3) and 1616a(2). In a general sense, each of the button teeth 1721, 1731, 1741 areengaged or nearly engaged with corresponding jawbone base teeth.Relatedly, leaf spring mechanism tab 1622 a is engaged with anengagement aperture (e.g. 1616 b, 1616 c as shown in FIG. 16M), thushelping to rotationally lock or restrain the jawbone base and thejawbone. As depicted in this proximal cross-sectional area of the baseassembly, jawbone 1614 defines an inner bore 1614 a, a wall thickness1614 b, and an outer radius 1614 c (e.g which corresponds to an outerdiameter 1614 c′ as shown in FIG. 16N). The outer surface of jawbone1614 interfaces with the inner surface of jawbone base 1616. In somecases, the jawbone is constructed as a tubular structure having an innerbore extending therethrough. The distal portion 1614 d of jawbone 1614is shows sweeping toward the left side of FIG. 16L.

When using the clamp device to squeeze or clamp a section of patienttissue T, the jaw mechanism 1612 presses against tissue T in thedirection indicated by arrow B. Consequently, an opposing force frompatient tissue acts upon the jaw mechanism in the direction indicated byarrow C. The clamping interaction between the jaw mechanism and thepatient tissue tends to rotate jawbone 1614 about an axis (e.g. 1614″)in the direction indicated by arrow D, thus creating a torque or moment.Various aspects of exemplary clamp systems, such as the frame button,jawbone base, and leaf spring, can operate to resist such rotationassociated with the tissue clamping torque. For example, when squeezingtissue with the clamp, a flat surface of the leaf spring tab 1622 a canpress against a flat surface of the leaf spring engagement aperture(e.g. 1616 b, 1616 c as shown in FIG. 16M), thus constraining rotationalmovement of the jawbone. Hence, aspects of the jaw base can operate toresist rotation of the jawbone during a clamping procedure. In this way,a curved parallel relationship between jawbones, guides, ablationapparatuses, electrodes, and the like can be maintained during use. Thethree dimensional structural relationship between the respectivejawbones, guides, ablation apparatuses, electrodes can withstand forceswhich would otherwise cause disalignment or splay between theseelements.

As shown in this transparent view from the proximal section of the baseassembly, the actuation is initiated by pressing against the framebutton engagement pad 1710 in the direction indicated by arrow A. As aresult, engagement face 1722 of upper tooth 1721 moves toward or engagestooth 1616 a(5). Further, engagement face 1732 of lower tooth 1731 movesaway from or disengages tooth 1616 a(8), and engagement ramp 1733 movestoward or engages tooth 1616 a(1). Relatedly, upper engagement face 1742of vertical arm tooth 1741 moves away from or disengages tooth 1616a(3). Moreover, the outer face of vertical arm 1740 moves toward orengages the inner face of leaf spring 1622.

As shown in FIG. 16M, as the operator maintains an engagement force onthe frame button engagement pad, button 1700 continues to move in adirection indicated by arrow A. At this step in the actuation process,upper horizontal frame tooth 1721 operates as the primary driver torotate jawbone 1614, by pressing against jawbone base tooth 1616 a(5) inthe direction indicated by arrow B. As described previously, jawbonebase 1616 includes two intersecting cylinders or bores 1616 b, 1616 cwhich provide engagement holes that receive a leaf spring tab 1622 a.The cross-section view of the proximal portion of the base assemblyshows the intersection between these two interior cylindrical surfacesor bores. When frame button shifts in the direction indicated by arrowA, an engagement point 1622 a′ of tab 1622 a slips along a correspondingengagement point 1616 b′ of jawbone base aperture 1616 b, as the buttonvertical arm 1740 pushes against leaf spring 1622 in the directionindicated by arrow C and as the upper arm tooth 1721 pushes againstjawbone base tooth 1616 a(5) to rotate jawbone base 1616 about axis1614″ in the direction indicated by arrow D. Engagement points 1616 b′and 1622 a′ just begin to clear as the frame button moves toward theright and lifts the leaf spring out of the engagement hole. Similarly,upper ramp surface 1742 of vertical frame arm 1740 begins to clearjawbone base tooth 1616 a(3) as frame button moves toward the right andtooth 1616 a(3) rotates in the clockwise direction. Relatedly, rampsurface 1733 of lower arm tooth 1731 and jawbone base tooth 1616 a(1)slide along each other, with tooth 1616 a(1) moving in the directionindicated by arrow E and tooth 1731 moving in the opposing directionindicated by arrow F. Accordingly, a central portion of lower horizontalframe arm 1730 flexes or bows downwardly in the direction indicated byarrow G. Lower frame arm 1730 curves in this manner due to the lowerframe tooth ramping away from the jawbone base tooth moving in theopposite direction.

In use, as a curvature develops in one horizontal arm, the opposingparallel horizontal arm may also develop a curvature due to the tensionin the vertical members. For example, as lower horizontal frame arm 1730flexes or bows downwardly in the direction indicated by arrow G, buttonvertical arm 1710 and frame button vertical arm 1740 are tensioned orpulled in a downward direction as indicated by arrows T1 and T2,respectively. This tension serves to create a bow or flex (not shown) inupper horizontal member 1720, and hence upper frame member tooth 1721then engages more firmly or with more force the jawbone base tooth (e.g1616 a(5)) located opposite to the jawbone base tooth (e.g. 1616 a(1))which is slidingly engaging ramp surface 1733.

Rotation of jawbone base 1616 leads to a corresponding rotation ofjawbone 1614 as indicated by arrow H. The central axis of rotation isaligned with the jawbone axis. Hence, FIG. 16M illustrates enhancedpositive engagement between the upper arm pawl tooth and ratchet tooth1616 a(5), such that movement of the frame button drives rotation of thejawbone base. The leaf spring tab is being pushed out of the jawbonebase engagement hole, optionally with a small amount of contact betweenthe two during a slipping action, providing a tight tolerance such thatthe tab slightly resists rotation of the jawbone base. As the tab slipsout of the engagement hole, this minor amount of interference may befurther reduced. Due to the ramping or wedging action between the lowerarm tooth and jawbone base tooth 1616 a(1), the lower frame element ispushed or bowed downwardly in a flexing motion. The contact pointbetween backside tooth 1616 a(3) and vertical arm tooth 1741 also beginto escape engagement.

With continuing reference to the push motion of the actuation procedure,FIG. 16N shows that as the operator maintains an engagement force on theframe button engagement pad, button 1700 remains moving in a directionindicated by arrow A. At this step in the actuation process, upperhorizontal frame tooth 1721 operates as the primary driver to rotatejawbone 1614, by pressing against jawbone base tooth 1616 a(5) in thedirection indicated by arrow B. Engagement point 1622 a′ of tab 1622 aand corresponding engagement point 1616 b′ of jawbone base aperture 1616b have now slipped past each other, as the button vertical arm 1740continues to push against leaf spring 1622 in the direction indicated byarrow C and as the upper arm tooth 1721 pushes against jawbone basetooth 1616 a(5) to rotate jawbone base 1616 about axis 1614″ in thedirection indicated by arrow D. Leaf spring tab is now lifted clear ofthe engagement hole. Similarly, tooth 1741 of vertical frame arm 1740 isnow clear of jawbone base tooth 1616 a(3) as frame button moves towardthe right and tooth 1616 a(3) rotates in the clockwise direction. Asramp surface 1733 of lower arm tooth 1731 and jawbone base tooth 1616a(1) slide along each other, with tooth 1616 a(1) moving in thedirection indicated by arrow E and tooth 1731 moving in the opposingdirection indicated by arrow F, maximal interference has been reachedand lower horizontal frame arm 1730 is fully flexed or curved downwardlyin the direction indicated by arrow G. Rotation of jawbone base 1616continues to lead to a corresponding rotation of jawbone 1614 asindicated by arrow H. The central axis of rotation is aligned with thejawbone axis. Hence, as depicted in FIG. 16N, the upper frame tooth 1721is deeply engaged with jawbone base tooth 1616 a(5), actively drivingrotation of the jawbone base. The leaf spring tab has completely escapedengagement with the jawbone base engagement aperture, and the verticalarm tooth has escaped engagement or lost contact with jawbone base tooth1616 a(3). With leaf spring tab removed, free rotation of the jawbonebase is allowed.

With further reference to the push motion of the actuation procedure,FIG. 16O shows that as the operator continues to maintain an engagementforce on the frame button engagement pad, button 1700 remains moving ina direction indicated by arrow A. At this step in the actuation process,upper horizontal frame tooth 1721 continued to operate as the primarydriver to rotate jawbone 1614, by pressing against jawbone base tooth1616 a(5) in the direction indicated by arrow B. Engagement tab 1622 ais now distanced from of the jawbone base aperture, as the buttonvertical arm 1740 continues to push against leaf spring 1622 in thedirection indicated by arrow C and as the upper arm tooth 1721 pushesagainst jawbone base tooth 1616 a(5) to rotate jawbone base 1616 aboutaxis 1614″ in the direction indicated by arrow D. Leaf spring tab 1622 ais now lifted well clear of the engagement hole, and as the operatorcontinues to press against frame button 1700, leaf spring 1622 continuesto load up with potential energy. Lower arm tooth 1731 and jawbone basetooth 1616 a(1) have slid sufficiently along each other, with tooth 1616a(1) moving in the direction indicated by arrow E and tooth 1731 movingin the opposing direction indicated by arrow F, such that frame tooth1731 has now dropped back behind jawbone base tooth 1616 a(1) as lowerhorizontal frame arm 1730 returns to an unflexed or straightenedconfiguration as indicated by arrow G. Thus, tooth 1616 a(1) has escapedramped engagement, and tooth 1731 is disposed between tooth 1616 a(1)and 1616 a(2). Rotation of jawbone base 1616 continues to cause acorresponding rotation of jawbone 1614 as indicated by arrow H. Thecentral axis of rotation is aligned with the jawbone axis. As depictedin FIG. 16O, the upper frame tooth 1721 is deeply engaged with jawbonebase tooth 1616 a(5), actively driving rotation of the jawbone base. Dueto a flat engagement surface or interface between tooth 1721 and tooth1616 a(5), which is substantially perpendicular to the upper horizontalframe member, there is little or no moment arm which would lead toflexing or bowing of the upper horizontal frame member as a result ofengagement between tooth 1721 and tooth 1616 a(5). However, as explainedwith reference to FIG. 16M, as a curvature develops in one horizontalarm, the opposing parallel horizontal arm may also develop a curvaturedue to the tension in the vertical members. Hence, as depicted in FIG.16Q, a bowing in upper horizontal arm 1720 may lead to a bowing in lowerhorizontal arm 1730, due to tension generated in vertical arms 1710 and1740.

With yet further reference to the push motion of the actuationprocedure, FIG. 16P shows that as the operator continues to maintain anengagement force on the frame button engagement pad, button 1700 remainsmoving in a direction indicated by arrow A, until frame button can moveno further. As shown here, the backside of engagement pad is contactingthe outer cylindrical surface of jawbone base 1616. Hence, the end ofthe first stroke or actuation is reached, and the jawbone has rotated 45degrees in the direction indicated by arrow H. At this step in theactuation process, upper horizontal frame tooth 1721 jawbone base tooth1616 a(5) in the direction indicated by arrow B substantially as far aspossible. Engagement tab 1622 a remains distanced from of the jawbonebase aperture, as the button vertical arm 1740 has pushed leaf spring1622 to a maximal extent in the direction indicated by arrow C thusfully loading leaf spring 1622 with potential energy. Lower arm tooth1731 and jawbone base tooth 1616 a(2) have slid sufficiently along eachother, with tooth 1616 a(2) moving in the direction indicated by arrow Eand tooth 1731 moving in the opposing direction indicated by arrow F,such that lower horizontal frame has flexed again during rampedengagement (not shown) between tooth 1731 and tooth 1616 a(2), andsubsequently frame tooth 1731 has now dropped back behind jawbone basetooth 1616 a(2) as lower horizontal frame arm 1730 returns to anunflexed or straightened configuration as indicated by arrow G.

Hence, as discussed above, FIGS. 16L-16P illustrate the push phase of apush-and-release actuation. As discussed below, FIGS. 16Q-16S illustratethe release phase of the push-and-release actuation.

As shown in FIG. 16Q, as the operator releases the engagement force onthe frame button engagement pad, button 1700 begins to move in adirection indicated by arrow A. Leaf spring 1622, now loaded withpotential energy, provides force in the direction indicated by arrow A′to press against button vertical frame member 1740. At this step in theactuation process, lower horizontal frame tooth 1731 operates as theprimary driver to rotate jawbone 1614, by pressing against jawbone basetooth 1616 a(2) in the direction indicated by arrow B. Relatedly, rampsurface 1723 of upper arm tooth 1721 and jawbone base tooth 1616 a(6)slide along each other, with tooth 1616 a(6) moving in the directionindicated by arrow E and tooth 1721 moving in the opposing directionindicated by arrow F. Accordingly, a central portion of upper horizontalframe arm 1720 flexes or bows upwardly in the direction indicated byarrow G. Upper frame arm 1720 curves in this manner due to the upperframe tooth ramping away from the jawbone base tooth moving in theopposite direction. Rotation of jawbone base 1616 leads to acorresponding rotation of jawbone 1614 as indicated by arrow H.

As explained with reference to FIG. 16M, as a curvature develops in onehorizontal arm, the opposing parallel horizontal arm may also develop acurvature due to the tension in the vertical members. Hence, as depictedin FIG. 16Q, a bowing in upper horizontal arm 1720 may lead to a bowingin lower horizontal arm 1730, due to tension generated in vertical arms1710 and 1740. For example, as upper horizontal frame arm 1720 flexes orbows upwardly in the direction indicated by arrow G, button vertical arm1710 and frame button vertical arm 1740 are tensioned or pulled in anupward direction as indicated by arrows T1 and T2, respectively. Thistension serves to create a bow or flex (not shown) in lower horizontalmember 1730, and hence lower frame member tooth 1731 then engages morefirmly or with more force the jawbone base tooth (e.g 1616 a(2)) locatedopposite to the jawbone base tooth (e.g. 1616 a(6)) which is slidinglyengaging ramp surface 1723.

As shown in FIG. 16R, as leaf spring 1622 continues to maintain anengagement force on frame button vertical member as indicated by arrowA′, button 1700 continues to move in a direction indicated by arrow A.Lower horizontal frame tooth 1731 remains the primary driver to rotatejawbone 1614, by pressing against jawbone base tooth 1616 a(2) in thedirection indicated by arrow B. As described previously, jawbone base1616 includes two intersecting cylinders or bores 1616 b, 1616 c whichprovide engagement holes that receive a leaf spring tab 1622 a. Thecross-section view of the proximal portion of the base assembly showsthe intersection between these two interior cylindrical surfaces orbores. When frame button shifts in the direction indicated by arrow A,an engagement point 1622 a″ of tab 1622 a slips along a correspondingengagement point 1616 c″ of jawbone base aperture 1616 c, as leaf spring1622 pushes against the button vertical arm 1740 in the directionindicated by arrow A′ and as the lower arm tooth 1731 pushes againstjawbone base tooth 1616 a(2) to rotate jawbone base 1616 about axis1614″ in the direction indicated by arrow D. Relatedly, ramp surface1723 of upper arm tooth 1721 and jawbone base tooth 1616 a(7) slidealong each other, with tooth 1616 a(7) moving in the direction indicatedby arrow E and tooth 1721 moving in the opposing direction indicated byarrow F. Accordingly, a central portion of upper horizontal frame arm1720 flexes or bows upwardly in the direction indicated by arrow G.Upper frame arm 1720 curves in this manner due to the upper frame toothramping away from the jawbone base tooth moving in the oppositedirection. As explained with reference to FIG. 16Q, bowing in upperhorizontal arm 1720 may lead to a bowing in lower horizontal arm 1730,due to tension generated in vertical arms 1710 and 1740, thus providingenhanced engagement between lower horizontal arm tooth 1731 and jawbonebase tooth 1616 a(2). Rotation of jawbone base 1616 leads to acorresponding rotation of jawbone 1614 as indicated by arrow H. Springtooth 1622 a begins to enter jawbone base engagement hole 1616 c.

With further reference to the release motion of the actuation procedure,FIG. 16S shows that as the operator continues allowing leaf spring 1622to maintain an engagement force on the frame button vertical member 1740as indicated by arrow A′, button 1700 remains moving in a directionindicated by arrow A. Tooth 1731 of lower horizontal frame member 1730has driven jawbone base tooth 1616 a(2) to the end of the strokeposition. Hence, the pawl frame can fully return to the startingposition, driven by the leaf spring. At this step in the actuationprocess, upper horizontal frame tooth 1721 is now positioned adjacentjawbone base tooth 1616 a(7), and poised to engage tooth 1616 a(7)during the next actuation of the frame button 1700. Engagement tab 1622a is positioned within engagement aperture 1616 c of jawbone base 1616,and vertical frame member tooth 1741 is positioned between jawbone baseteeth 1616 a(5) and 1616 a(4). Hence, spring tooth 1741 is situated forfully engaging the jawbone base teeth to take rotational loads. As shownhere, jawbone 1614 has been rotated in the direction indicated by arrowH to a ninety degree angle relative to the position shown in FIG. 16L,and the button frame is now in the original position shown in FIG. 16L.By cycling through another push-and-release actuation, it is possible torotate the jawbone an additional ninety degrees.

In some cases, a three (or multiple) segment electrode,double-(multiple) hinged pair of jaws can have hinges allowing sidewaysmovement in each jaw. Such configurations allow the implementation of aleft or right curve of variable radii or an S-curve, which may or maynot be smooth curves, optionally including straight segments. In somecases, the entire shaft and jaw can be detached just distal to thehandle, for example instead of midway on the body or more one bodyinside the other, with a connector for the electronics. There can bedifferent jaw sets for right and left curves, and the like.

A mono/bi-polar convertible device can include coupling for electricaland water lines, or an electrical connector and mechanical guidefeatures to connect the two body parts. Systems may also includeexternal folding or hinging features to lock them into place. Aconvertible bi/monopolar couple mechanism can include a hinge mechanismto temporarily straighten a jaw at a crux to allow insertion of amonopolar assembly into a jaw. A convertible bi/monopolar couplemechanism can also include an enclosed jaw channel, such as a tunnel inthe jaw for an electrode to pass within, with features to increasesurface contact between an electrode and a tunnel roof or tissuecontacting energy transmission member. Such configurations can guide amalleable monopolar electrode while recoupling the devices back into abipolar position where an active or monopolar electrode is positionedparallel with the opposed indifferent electrode. In some cases, systemscan include discrete bands or snap-in “over-center” electrode constraintfeatures, or a continuous mesh over top or tunnel roof that is fixed orretractable and that contains an ablation member or electrode.Embodiments may also include a hinge at the shaft and jaw interface forcoaxial orientation and port access introduction. Further, embodimentsmay include an introducer attachment to a jawbone having articulationand/or steerability, using magnets, with an integrated light/camera.Embodiments also encompass closed loop lasso introduction systems andmethods.

According to some embodiments, the treatment systems and methodsdescribed herein may be used in conjunction or combined with aspects ofintroducer systems and methods such as those described in U.S. patentapplication Nos. 60/337,070 filed Dec. 4, 2001; Ser. No. 10/272,446filed Oct. 15, 2002; Ser. No. 10/310,675 filed Dec. 4, 2002; Ser. No.10/410,618 filed Apr. 8, 2003; Ser. No. 11/148,611 filed Jun. 8, 2005;60/939,201 filed May 21, 2007; 61/015,472 filed Dec. 20, 2007;61/051,975, filed May 9, 2008; Ser. No. 12/124,743 filed May 21, 2008;Ser. No. 12/124,766 filed May 21, 2008; Ser. No. 12/255,076 filed Oct.21, 2008; Ser. No. 12/273,938 filed Nov. 19, 2008; Ser. No. 12/339,331filed Dec. 19, 2008; Ser. No. 12/463,760 filed May 11, 2009; 61/179,564filed May 19, 2009; 61/231,613 filed Aug. 5, 2009; and 61/241,297 filedSep. 10, 2009. The entire content of each of these filings isincorporated herein by reference for all purposes.

Relatedly, in some instances, the treatment systems and methodsdescribed herein may include elements or aspects of the medical systemsand methods discussed in U.S. patent application Nos. 60/337,070 filedDec. 4, 2001; Ser. No. 10/080,374 filed Feb. 19, 2002; Ser. No.10/255,025 filed Sep. 24, 2002; Ser. No. 10/272,446 filed Oct. 15, 2002;Ser. No. 10/310,675 filed Dec. 4, 2002; Ser. No. 10/410,618 filed Apr.8, 2003; Ser. No. 11/067,535 filed Feb. 25, 2005; Ser. No. 11/148,611filed Jun. 8, 2005; 60/939,201 filed May 21, 2007; 61/015,472 filed Dec.20, 2007; 61/051,975, filed May 9, 2008; Ser. No. 12/124,743 filed May21, 2008; Ser. No. 12/124,766 filed May 21, 2008; Ser. No. 12/255,076filed Oct. 21, 2008; Ser. No. 12/273,938 filed Nov. 19, 2008; Ser. No.12/339,331 filed Dec. 19, 2008; Ser. No. 12/463,760 filed May 11, 2009;61/179,564 filed May 19, 2009; 61/231,613 filed Aug. 5, 2009; and61/241,297 filed Sep. 10, 2009. The entire content of each of thesefilings is incorporated herein by reference for all purposes.

While the exemplary embodiments have been described in some detail, byway of example and for clarity of understanding, those of skill in theart will recognize that a variety of modification, adaptations, andchanges may be employed. Hence, the scope of the present inventionshould be limited solely by the claims.

What is claimed is:
 1. A treatment system for forming a lesion on atissue of a patient, comprising: an actuator handle assembly; and aclamp assembly coupled with the actuator handle assembly, the clampassembly having a first jaw mechanism and a second jaw mechanism,wherein the first jaw mechanism comprises a first rotatable guide, and afirst flexible ablation member in operative association with the firstrotatable guide, wherein the second jaw mechanism comprises a secondrotatable guide, and a second flexible ablation member in operativeassociation with the second rotatable guide, wherein the first jawmechanism comprises a first flexible boot, the first flexible ablationmember is coupled with the first flexible boot, and the first rotatableguide is disposed at least partially within the first flexible boot,wherein the second jaw mechanism comprises a second flexible boot, thesecond flexible ablation member is coupled with the second flexibleboot, and the second rotatable guide is disposed at least partiallywithin the second flexible boot, and wherein the first and secondflexible boots are configured such that the first and second ablationmembers face toward each other upon rotation of the first rotatableguide, upon rotation of the second rotatable guide, or upon rotation ofboth the first rotatable guide and the second rotatable guide.
 2. Thetreatment system according to claim 1, wherein the first flexibleablation member comprises a serpentine electrode or a fishboneelectrode.
 3. The treatment system according to claim 1, wherein thesecond flexible ablation member comprises a serpentine electrode or afishbone electrode.
 4. The treatment system according to claim 1,wherein the first and second ablation members face toward each otherupon rotation of the first rotatable guide, the second rotatable guide,or both.
 5. The treatment system according to claim 1, furthercomprising a cooling system having a fluid return lumen, and a fluiddelivery lumen disposed within the fluid return lumen.
 6. The treatmentsystem according to claim 1, comprising a member selected from the groupconsisting of a pull and rotate rotational assembly, a ball and detentrotational assembly, a side ratchet rotational assembly, a tuning forkrotational assembly, and a push and release rotational assembly.
 7. Thetreatment system according to claim 1, further comprising aradiofrequency generator capable of delivering a radiofrequency powersignal to the clamp assembly.
 8. The treatment system according to claim1, wherein the first ablation element comprises a member selected fromthe group consisting of a radiofrequency ablation element, an infraredlaser ablation element, a high intensity focused ultrasound ablationelement, a microwave ablation element, a cryoablation ablation element,a chemical agent ablation element, a biological agent ablation element,and a radiation ablation element.
 9. The treatment system according toclaim 1, wherein the first and second jaw mechanisms are configured toprovide an ablation zone shape that rotates as a result of rotation ofthe first and second guides.
 10. A treatment system for ablating atissue of a patient, comprising: an actuator handle assembly; and aclamp assembly coupled with the actuator handle assembly, the clampassembly having a first jaw mechanism and a second jaw mechanism,wherein the first jaw mechanism comprises a first flexible boot, a firstrotatable guide disposed at least partially within the first flexibleboot, and a first flexible ablation member coupled with the firstflexible boot, and wherein the second jaw mechanism comprises a secondflexible boot, a second rotatable guide disposed at least partiallywithin the second flexible boot, and a second flexible ablation membercoupled with the second flexible boot.
 11. The treatment systemaccording to claim 10, wherein the first flexible ablation member iscoupled with the first flexible boot by a mechanical connection.
 12. Thetreatment system according to claim 10, wherein the first flexibleablation member is coupled with the first flexible boot by a chemicalconnection.
 13. The treatment system according to claim 10, wherein thefirst flexible boot comprises a polymer sleeve.
 14. The treatment systemaccording to claim 10, wherein the first flexible boot comprisesurethane.
 15. The treatment system according to claim 10, wherein thefirst flexible boot is a closed-end boot.
 16. The treatment systemaccording to claim 10, wherein the first flexible boot and the firstflexible ablation member are configured to flex in unison.
 17. Thetreatment system according to claim 10, wherein the first rotatableguide is configured to rotate throughout an angular range while thefirst flexible boot remains rotationally stationary.